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V l a d i m i r V e s e l o v, H e l e n Ro y tm a n , a n d Lo r i A l q u i e r

Table I: FDA Warning Letters.


Date

Company

Link

Observation

September
18, 2009

Advanced Medical
Optics Uppsala Ab

http://www.
fda.gov/ICECI/
EnforcementActions/
WarningLetters/
ucm193872.htm

Failure to adequately ensure that when the results


of a process cannot be fully verified by subsequent
inspection and test that the process shall be validated
with a high degree of assurance and approved according
to established procedure, as required by 21 C.F.R.
820.75(a).
For example, your firm failed to perform and document
equipment-cleaning validation for the production of
Healon D ophthalmic viscoelastic devices.

April 11,
2008

VIBE Technologies,
LLC

http://www.fda.gov/
foi/warning_letters/
s6745c.htm

5. Failure to establish and maintain procedures


to ensure that equipment is routinely calibrated,
inspected, checked, and maintained, as required by 21
CFR 820.72(a).

April 26,
2007

Medical Wire &


Equipment Co
(Bath), Ltd.
Potley Road
Corsham, Wiltshire,
England SN13 9RT

http://www.fda.gov/
foi/warning_letters/
s6345c.htm

4. Failure to ensure all inspection, measuring, and test


equipment, is suitable for its intended purposes and
is capable of producing valid results as required by
21 CFR 820.72(a); and failure to document equipment
identification, calibration date, the individual performing
the calibration, and the next calibration date as required
by 21 CFR 820.72(b)(2). For example, there is no
documented calibration history for the [redacted] which
is used to test the conductivity of the process water.

June 1,
2006

Visionary Contact
Lens, Inc.
2940 E. Miraloma
Ave.
Anaheim, CA 92806

http://www.ortsedu.
com/warning1.pdf

9. You have not completely established procedures


to ensure that equipment is routinely calibrated.
Specifically, the daily check of manufacturing
equipment is not described or referenced [21 CFR
820.72(a)].

September
28, 2007

Healthway Home
Products, Inc.
4941 N. Jefferson
St.
Pulaski, New York
13142-4102

http://www.fda.gov/
foi/warning_letters/
s6543c.pdf

8. Failure to establish and maintain procedures to


ensure that inspection, measuring and test equipment is
routinely calibrated, inspected, checked and maintained,
as required by 21 CFR 820.72(a). For example, written
procedures have not been established for acceptance
testing equipment (i.e. digital high voltage meter and
particle counter) utilized on Air Cleaners prior to
distribution to assure the testing equipment
are routinely calibrated and properly maintained.

December
2, 2005

Restorative
Products, Inc.
13560 Wright Cir
Tampa, FL 33626

http://www.
casewatch.org/
fdawarning/
prod/2005/
restorative.shtml

Your firm failed to establish and maintain procedures


to ensure that equipment is routinely calibrated,
inspected, checked, and maintained as required by 21
CFR 820.72(a). In particular, your firm did not establish
and maintain procedures for calibrating temperature
and speed controls on wave soldering equipment and
an oven. (FDA 483, Item #7).
Your firm failed to establish and maintain procedures to
control environmental conditions that could reasonably
be expected to have an adverse effect on product
quality as required by 21 CFR 820.70(c). Your firms
soldering work instructions require that sensitive
components and circuit boards, when not being worked
on, must be enclosed in shielding bags or boxes. The
investigator observed a minimum of 10 antistatic bags
containing sensitive components and p.c. boards in
open bags in the storage area (FDA 483, Item #8).

g x p a n d j v t . co m

Journal of Validation Technology [SPRING 2012] 89