AMhla-
Food and Drug Administration
555 Winderly Place, Suite 200
Maitland, FL 32751
Telephone: (407) 475-4700
FAX: (407) 475-4768
FEI: 3006723358
From: Kelly M. McNeill, Craig A. Gannendia
Investigators, Florida District
Subject: Investigation into the contamination of Avastln and the subsequent outbreak of
Streptococcus mitis/ orahs in patients with wet age-related macular degeneration (AMD).
FACTS assignment # 1305865 requested a visit to Walgreens for information regarding recalled lots of
Avastin in which 12 cases of Streptococcus mitis/ orohs were reported to have infected patients' eyes.
The assigrunent also instructed to collect samples of product still available from affected lots.
TO:
This memo summarizes the investigation into Avastin contamination that was distributed by Walgreens,
dba Chroniscript, and the subsequent outbreak of Streptococcus mitis/orohs in patients with AMD.
Investigators obtained information from the distributor and doctors that treated the patient's with the
infection, along with culture reports fro (b) (4) _
nvestigator
0: HFR-SE250/HFR-SE240 (lvlBT)/HFR-SE230
cc: HFR-SE2595 (Recall-WAL)
Jcc: HFR-SE2590 (lvlSD)
cc: HFR-SE2585 (DAD)
I of 5
On 07120111, Investigator McNeill and I arrived at Walgreens and spoke with an Eduardo (nmi) Ruiz,
General Manager of Walgreens Store # 15106. The Florida Department of Health (DOH) anived at
Walgreens shortly thereafter. We spoke with an Ann Schmitz, Regional Epidemiologist, and Luis
Nieves, Operations Management Consultant Manager, and indicated that we were there about the
Avastin issue. DOH notified us that they were there for a routine inspection of the facility.
Through discussions with Mr. Ruiz, it was determined that Walgreens bought Chroniscript in May 2011
and is now dba Chroniscript. Mr. Ruiz described the operations of his Walgreens facility as it pertains
to Avastin. Doctors at various eye centers in South Florida write a prescription for Avastin, the
prescription is sent to Walgreens who in retum orders the phmmaceutical which is obtained from (b) (4)
(b) (4) Please see Attachment # 1 for copies of the Avastin invoice from (b) (4)
(b) (4) as the distributor. The Avastin is delivered from
Walgreens to Infuphmma LLC. where the product is partitioned into separate one-time-use syringes for
each prescription and returned to Walgreens. Please see Attachment # 2 for copies of Walgreens pick-
up/ delivery slips. Finally, the product is delivered to each individual doctor's office for use, after
Walgreens has labeled each syringe package with the patient's infOlmation on it. Please see Attachment
# 3 for a copy ofthe legal agreement between Walgreens and Infuphanna.
Mr. Ruiz indicated that the finn became aware of infections with regards to the Avastin on July 10,
2011, and that by July II, 2011 all doctors had been notified of the potential issue via phone call. In
addition Walgreens released a primary recall notice identifying the indicated lots, 06222011 thru
07072011 and instructing that the lots be quarantined. Walgreens released a second noticed on July 15,
20 II broadening the recall to include every lot of Avastin. The recall instmcted consignees to
discontinue the use and distribution of Avastin. The instructions went on to request quarantining the
product and contacting Chroniscript for further instructions. In addition, the clinics were to count and
record the number of syringes they possessed. Please see Attachment # 4 for a copy of the two recall
notices released. Please see Attachment # 5 for a copy of a report of Avastin lots prepared. Please see
Attachment # 6 for a copy of a report of patients who received Avastin from May 4,2011 thru July 7,
2011. Please see Attachment # 7 for an Avastin MD distribution list.
In regards to the infections, Mr. Ruiz indicated that the firm was aware of 12 infections that had
occurred. Mr. Ruiz was aware of nine infections a (b) (4) two infections at the
(b) (4) , and one infection at th (b) (4) To Mr. Ruiz's knowledge(b) (4)
(b) (4) which handled the medication for some of the doctors, had six unused syringes and
(b) (4) had four syringes. Mr. Ruiz had no knowledge of syringes at the(b) (4)
(b) (4) The syringes not at Walgreens were sampled by DOH. An overview of the lots in
quarantine at Walgreens found no unused syringes for the lots associated with the initial recall.
However, numerous syringes were identified as being of interest to HQ, and thus were sampled on July
21,2011; these included: Sample # 704999 (14 - 1 cc unused syringes - lot # 07072011 and I -
unopened [not used to fill syringes but reported to be same parent Genentech lot] 16 mL vial of Avastin
-lot # 8834496), Sample # 705000 (1 - 1 cc used syringe - lot # 06222011), and Sample # 705001 (2-
1 mL unused syringes - lot # 07112011 and 1 - opened [reported to be used in the filling of syringes] 16
mL vial of Avastin - lot # 8834496).
A documentary sample was collected (DOC 679739) in which Mr. Ruiz signed an affidavit on July 21,
2011 stating the documents dealing with shipments of Avastin in which Walgreens received the
phannaceutical from(b) (4) , delivered the phmmaceutical to Infuphamla, received the filled syringes
from Infupharma, and delivery of the syringes to customers. The affidavit also stated the infonnation
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about the recall. Please see Attachment # 8 for a copy of the signed affidavit with sample number DOC
679739.
On July 25, 2011 Investigator McNeill and I visite (b) (4) . (b) (6), (b) (4) ,
Administrator and COO, informed us that 45 patients were injected with the affected lot, but only two
patients were infected. Please see Attachment # 9 for a list of patients injected with Avastin since June
23, 2011. He notified us that Holly Montejano fi'om DOH had been in contact with him. (b) (6), (b) (4)
indicated that only (b) (6), (b) (4) performed the injections of Avastin. We were able to talk with (b) (6), (b) (4)
via telephone call. (b) (6), (b) (4) was able to describe the procedure for the Avastin injections. Please see
Attachment # 10 for the procedure. The following day the patients were seen, two patients showed
signs of an infection, taps were taken, and were subsequently prescribed vancomycin and amikcain.
Three days later taps showed patients were positive and were subsequently prescribed vancomycin and
terramycin. The following day the patients received a vitrectomy. (b) (6), (b) (4) indicated that the patients
are progressing well but that at least minor eye damage will be permanent. (b) (6), (b) (4) provided the
documentation fi'Oln the patients' charts from the date of the procedure that caused the infection to July
25,2011.
On July 25, 2011 Investigator McNeill and I visite (b) (4) (b) (4) We spoke
to a (b) (6), (b) (4) , Ophthalmology Technician, in the waiting room of the facility.
Investigator McNeill asked if we could go somewhere quieter in order to discuss why we were there.
(b) (6), (b) (4) stated no and instructed us to contact (b) (6), (b) (4) and schedule a meeting
with her. She went on to say that they were instructed by DOH and the Center for Disease Control and
Prevention (CDC) not to give documents to the FDA without the meeting. I asked (b) (6), (b) (4) who
told them this and she responded with the names (b) (6), (b) (4) , (b) (6), (b) (4) , and a
(b)(4)
fourth person for which she had no name. I then clarified with(b) (6), (b) (4) tha (b) (4) would not be
willing to give us the documents we requested, she confilmed this statement, and we left the fum. After
talking (b) (6), (b) (4) in a conference call between FDA, CDC, and DOH on July 27, 2011, (b) (6), (b) (4)
was offered an invitation to join FDA in attempting to retrieve records from(b)(b)(4)
(4) (b) (6), (b) (4) declined
the invitation.
On July 28, 2011 I called (b) (4) at 10:22am and spoke with a (b) (6), (b) (4) , Office
Manager. After describing the documents we were attempting to collect, (b) (6), (b) (4) indicated she
needed to deliver the message to (b) (6), (b) (4) and she would have to return our call in roughly an hour
after (b) (6), (b) (4) was out ofa meeting. After not receiving a call, I called (b) (4) at 1:18pm at which
point (b) (6), (b) (4) indicated that (b) (6), (b) (4) fi'om the CDC told (b) (6), (b) (4) to have the FDA
contact him. I explained to (b) (6), (b) (4) that (b) (6), (b) (4) is fi'om DOH, which is a state agency, and
not CDC, which is a federal agency. I went on to explain that we had talked with (b) (6), (b) (4) the previous
day and that the FDA, a federal agency, has no direct connection to the state agency. I further stated the
Jaws and regulations that give FDA the authority to request and receive the patients' records as it relates
to the outbreak that was linked to an FDA regulated product. (b) (6), (b) (4) indicated she would relay
the message to (b) (6), (b) (4) and we would be contacted within the half hour. I contacted (b) (4) at
2:43pm and was told by the receptionist that (b) (6), (b) (4) and .(b) (6), (b) (4) were not available. I
stressed the importance of the matter and that the failure to contact me in a half hour would result in my
.supervisors being notified and the issue would have to be resolved through them.
On August 3, 2011 I was instructed by management to return to (b) (4) to obtain the medical records. I
was also instructed to take a box of office paper to the firnl in order to obtain the records. Upon aniving
I showed my credentials to (b) (6) and(b) (6), (b) (4) . The records for the nine infected patients
were provided, but (b) (6) requested a receipt to prove that I had acquired the documents. After
30f5
approval from Supervisor Gorney, I provided a hand written note indicating I had acquired the patients'
records. Please see Attachment # 11 for the hand written note. Upon my departure from (b) (4) I left
the box of office paper as instructed.
On July 26, 20 II Investigator McNeill and I visited (b) (4) also known as
(b) (4) according to Walgreens, and spoke with (b) (6), (b) (4) , Administrator.
(b) (6), (b) (4) indicated that she was notified of the issue on July 10, 2011 via a telephone message fiom
Walgreens and received a recall notice on July 12, 2011, but complained that the recall notice did not
provide good instructions. (b) (6), (b) (4) indicated that the firm had issues with tracing back the lot
numbers with the syringes used because the syringes did not have the lot code on the syringe packages.
Per the example she gave us, the outer package did not have the lot code but the inner packaging did
have the lot code on it, please see Attachment # 12. (b) (6), (b) (4) did provide a list of patients that were
injected with Avastin obtained from Walgreens from June 22, 2011 to July 11, 2011, please see
Attachment # 13. (b) (6), (b) (4) stated that all patients on the list provided had checkups and only one
patient presented with symptoms of an infection. (b) (6), (b) (4) provided that patient's medical record
for the treatment through July 26, 2011 at their facility, but that the patient was referred to (b) (4)
Also, (b) (4) sent three unused syringes of Avastin to
(b) (4) for sterility testing. (b) (6), (b) (4) was aware that one syringe tested positive for contamination,
one syringe tested negative, and one syringe she had no results for. She notified us that Holly
Montejano from DOH had been in contact with her.
On July 27, 2011 I contacted (b) (4) via telephone in order to obtain the sterility report for the tested
syringes and medical records for the patients' from (b) (4) (b) (6), (b) (4) provided the contact information
for (b) (6), (b) (4) Microbiologist, and (b) (6), (b) (4) Ophthalmologist. While trying to get into
contact with (b) (6), (b) (4) I spoke with (b) (6), (b) (4) Laboratory Teclmician, who explained to me that
(b) (6), (b) (4)
was currently on vacation. She went on to explain that (b) (6), (b) (4) had provided the infol1nation to
the Miami-Dade Health Department. The contacts at the location to which the reports were sent are
(b) (6), (b) (4) and (b) (6), (b) (4) This infol1nation was provided to management. I attempted to contact
(b) (6), (b) (4) and in the course of doing so spoke with (b) (6), (b) (4) She explained to me that (b) (6), (b) (4)
was on vacation and that the medical records would have to be obtained from the Medical Records
Department. (b) (6), (b) (4) an ophthalmologist who has seen the (b) (4) patient, called me. He
explained to me that he has seen the patient, but that (b) (6), (b) (4) is the physician of record. (b) (6), (b) (4)
also explained that (b) (4) has not prescribed any treatment different from her doctors at (b) (4) He went
on to say that he believes that the patient's vision is permanently damaged. I contacted the Medical
Records Department and spoke with (b) (6), (b) (4) she stated that she would not be able to
release the records without the patient's signature. T explained to (b) (6), (b) (4) the applicable regulations
and laws that give FDA the authority to obtain the medical records in question without the patient's
signahrre. She indicated that this would have to be handled by individuals higher up and to fax the
info11nation over.
On July 29, 2011 Tvisited (b) (4) and obtained medical records. I met with (b) (6), (b) (4) Chief Nursing
Officer, and (b) (6), (b) (4) Executive Director of Quality Management. (b) (6), (b) (4) spoke
with (b) (6), (b) (4) Interim Privacy Officer, who requested a signed document from FDA requesting
the information. I informed (b) (6), (b) (4) that FDA is not required to provide such documentation; I did
offer her an unsigned f011n FDA 461 with the patient in question'S name. (b) (6), (b) (4) agreed this
would be acceptable and that (b) (6), (b) (4) would provide the documentation I requested. (b) (6), (b) (4)
also explained that (b) (4) had also examined nine other patients linked to this outbreak and
(b) (6), (b) (4)
subsequently provided the names of these patients. I amended the f01111 FDA 461 to include the names
of the additional nine individuals. (b) (6), (b) (4) explained that the (b) (4) patient had an incomplete
40f5
medical record because a proper medical file was not created on the first visit; this led to documents
from that visit to disappear. She indicated that they were in the process of trying to track down the
patients that were seen by (b) (4)
(b) (4)
missing documents. I received all the medical records for the
(b) (6), (b) (4) Administrative Assistant, explained to me that the copies provided do not
include the ultrasounds, because of the recording materials inability to be photocopied with clarity.
On August 8, 2011 I contacted (b) (6), (b) (4) in order to obtain results from (b) (6), (b) (4)
culture results from nine separate patients with known infections and five unused syringes. All nine of
the patients' cultures were positive for Streptococcus mitis/ oralis. The lot number used on these
patients was 07062011. As for the syringes all tlu'ee sytinges of lot 07062011 were positive for
Streptococcus mitisi/oralis. Lot 06222011 showed no growth; while lot 07012011 was positive for
Streptococcus mitis/oralis. Please see Attachment # 14 for a copy of (b) (6), (b) (4) culture report.
For a summary of Avastin lots and infections by clinics, please see Attachment # 15.
Per request from OEO, the medical records were sent directly to CDER's Office of New Drugs, Dr.
Wiley A. Chambers, without being photocopied or included as an exhibit in this memo.
On August 16, 20 11, two syt'inges were collected from DOH. These syringes were apart of a sample
collection they had conducted. That sample collection was sent to CDC from analysis, but the two
syt'inges obtained from DOH were not analyzed. The sample number for these two syringes is 1NV
601149.
Attachments
I. (b) (4) Medical Invoice documenting the sale of Avastin to Walgreens (3 pgs)
2. Walgreens Pick-up/ Delivery Slips for InfuPhal111a and eye clinics (II pgs)
3. Contract between Walgreens and InfuPhmma (2 pgs)
4. Drug Recall Notices dated July 11,2011 and July 15, 2011 (2 pgs)
5. Avastin Lots Prepared (l pg)
6. Avastin Orders (6 pgs)
7. Avastin MD Distribution List (1 pg)
8. Signed Affidavit copy (1 pg)
9. (b) (4) Avastin Injection List (28 pgs)
10. Avastin Injection Procedure (1 pg)
11. Hand Written Receipt Note to (b) (4) (I pg)
12. Photocopy of Avastin Labeling from Walgreens at (b) (4) (1 pg)
13. (b) (4) Patient Summary of Avastin from Walgreens (I pg)
14. (b) (4) Patient and Avastin Culture Results (I pg)
15. Avastin Lot Flow Chmt (1 pg)
-~ )
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"raig A. Garmendia, CSO
MIA-RP Domestic Operations
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hODRESS . ----------'P"'H"'O"'N'""- . - - - - - - . - - - - - - 7/7/11 ~2:52 II
(b) (4)
d/b/a Chroniscript, a Florida corporation ("Chroniscript").
By;,-..-f...~&d.j~~-r.:--=--::::=<,...----::-
Printed Nllllle:,~-..,..<=~,-,c-"-,,,,=~,--_
Its; -.IF-~""""~ _
July, II 2011
Re: AVASTIN
Package Size: .10ML Injection
Lot Number: 06222011 - 07072011
Dear ':;ustomer:
Chror isrrjpt Phannacy is recalling AVASTIN - .10mI Injection Lots number 06222011
through 07072011. This lot is being recalled because it is suspect in contamination.
Please examine your inventory immediately and DO NOT USE. Call us at 305-547-4790 to
anange return all units of AVASTIN - .10mI Injection Lots number 06222011 through
07072011.
Stop distributing and immediately quarantine the referenced lot number only. Please carry out a
physical count and record this data.
July, IS 2011
Dear Customer:
The Florida Department of Health has requested an expanded recall of AVASTIN injection
syringes dispensed by Chroniscript pharmacy. Chroniscript requests that ANY and EVERY
AVASTIN syringe that might be in your practice be removed from use and contact us for further
instructions.
Please examine your inventory immediately and DO NOT USE. Call us at 305-547-4790 to
arrange return all units of AVASTIN.
Stop distributing and immediately quarantine the referenced Avastin. Please carry out a physical
count and record this data.
FEI' 3006723358
WalgreenS Co. . G
EI' 07/20/11 - 08/16/11 KMM. CA
Aliaehment _4_ Total pgs _2_ Page 2
Avastin Lots Prepared
Lot Date Lot Number Units In Lot Avatin Lot Avastin Exp.
5/5/2011 5052011 11 878460 6/30/2012
5/11/2011 5112011 26 878463 6/30/2012
5/25/2011 5/25/2011 60 852712 4/30/2012
6/8/2011 6082011 48 878460 6/30/202
6/21/2011 6212011 16 879296 7/30/2012
7/1/2011 7012011 4 879296 7/30/2012
7/5/2011 7052011 30 879296 7/30/2012
7/6/2011 7062011 15 879296 7/30/2012
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AVilstin MD Distribution List
I am the General Manager of Walgreen's Pharmacy Store #15106 DBA Chroniscript, and as such I have
knowledge of the firm's receipt, storage, and delivery of Avastin. I have held the position of General
Manager at Chronoscipt since 2005. When Chroniscript was bought by Walgreen's Pharmacy on 5/1/11,
I continued to hold the same position.
On 5/31/11, my firm received 4 -lOOMG vials of Avastin Lot #879296(4) from (b) (4)
. This shipment was delivered to
my fIrm, and is documented by Invoice #12010189133, dated 5/31/11. This invoice acts as a Bill of
Lading. This shipment was sent to Infupharma of Hollywood, FL in sealed bags. My firm received
reconstituted Avastin in syringes packaged in sealed bags from this lot on 6/22/11, 7/1/11, 7/5/11, and
7/7/11. The corresponding lots assigned to the syringes by Infupharma are 6222011, 7012011, 7052011,
and 7072011, respectively. However, documentation provided to Walgreen's by Infupharma shows the
lot dates as 6/21/2011 and 7/6/201 I .
I verified and provided the following documents to CSOs Kelly M. McNeill and Craig A. Garmendia:
Invoice #12010189133, dated 5/31/11, Invoice #12010173806, dated 5/11/1 1, Invoice #12010218946,
dated 7/5/11, the pharmacy agreement between Walgreen's and Infupharma, the distribution list of
Avastin, Avastin patient information,shipment documentation of bulk'Avastin vials to Infupharma and
shipment documentation of reconstituted Avastin from Infupharma to Chroniscript from 5/5/1 I through
7/6/11, and the two recall notices ofAvastin dated 7/11/11 and 7/15/11. My firm first became aware of
adverse reactions to Avastin on 7/10/11. Wayne Talamas, Pharmacy Manager of Chroniscript received
a phone call from a physician whose patient who took Avastin and consequently became infected.
I have received 12 reports of infection from Avastin patients from physicians.
\Valgreen's Pharmacy DBA Chroniscript 1250 NW 7th St. Ste 205 Miami. FL 33136
Miami, Florida
Subscribed and sworn to before me at ~-----------,r==,=r-----------'
(Civ and State)
this 21st Ju1y
day of__ :
Employee of the Department of Health and Human Services designated under Act of January 31, 1925, Reorganization Plan TV effective
June 30,1940; Reorganization Plan No. I of 1953, ctfective April II, 1953; and P.L. 9688, effective May 4,1980.
FORMFbA 463a (5/07) rSC(Or;,h",(Ml}~HIO)Ij EF Page 1 of 1
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Attachment _9_ Total pgs _28_ Page 19
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These are the procedures as stated to us by (b) (6) :
(b) (6) applied 2 drugs (uudecipherable) to the eye. He then applied one drop of butadiene to
the eye. He then removed the sterile lid speculum and injected Avastin. He applied a drop of
antibacterial medicine, and replaced the sterile lid. (b) (6) followed up with patients. He
administered Vancomycin and Amikacin. He conducted a vitrious tap and antelior chamber tap,
which are typical procedures. The taps came back positive for growth. He administered more
vancomycin and triamcinolone intraventricularly. He conducted a vitrectomy and a vitrious
biopsy, and administered more vancomycin. For the second affected patient, the vitrectomy was
conducted, and the patient was administered triamcinolone.
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PATIENTS ON CHRONISCRIPT LIST LOT#/RX# IJECTION DA")RUG RECEIVE[ ADDITIONAL COMMENTS
131303 7/8/2011 7/6/2011 Patient dx with infection & treated on 7/11/11 sent to (b) (4) on 7/13/11
7/12/11
130450 No inj given 7/5/2011 Prefilled syringe sent to (b) (4) 7/12/11
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