|
Originalzitat Warning Letter |
Firma / Datum |
|
"Failure to have written procedures that describe the
handling of all written and oral complaints of possible failure of a
drug product include a provision for review of the complaint by
the quality control unit. In addition, the complaint files
reviewed during the inspection did not contain a
discussion of the results of the investigations or give a
description of the nature of the complaint [21 CFR 211.198(a)
& (b)(l)]." |
Savant Medical Supply, Inc.;
Forest Park, IL / 09.03.01 |
|
"Failure to have adequate complaint procedures established
in that instructions concerning FDA post-marketing adverse
drug experiences do not describe what needs to be reported or
establish timeframes for reporting [21 CFR 211. 198(a)]." |
Veterinary Laboratories, Inc.;
Lenexa, KS / 16.04.01 |
|
"Failure to establish written procedures that
describe the handling of all oral and written complaints regarding a
drug product as required by 21 CFR 211.198 (a)." |
Grafor Manufacturing, Inc.;
Ponce, PR / 20.04.01 |
|
"Additionally, you have failed to establish written
operating procedures for drug production and process control steps.
For example, for … complaint handling procedures (21 CFR
211.198)." |
Farouk Systems, Inc.;
Houston, TX / 01.08.01 |
|
"Failure to establish written procedures that
describe the handling of all written and oral complaints regarding
Oxygen, USP, filled at your facility [21 CFR 211.198(a)]." |
Baker's Pharmacy;
Winchester, IL / 17.08.01 |
|
"Failure to maintain complaint handling procedures to
include provisions for review to determine whether the
complaint represents a serious and unexpected adverse drug
experience which is required to be reported to FDA [21 CFR
211.198(a)]." |
Iso-Tex Diagnostics, Inc.;
Friendswood, Texas / 08.11.01 |
|
"Failure to establish written procedures (21 CFR …
211.198) for the following: The handling of written and oral
consumer complaints." |
Pharmaceutical Distribution Systems;
Montclair, Virginia / 03.01.02 |
|
"Failure to establish and follow adequate procedures
for handling and investigating complaints regarding product quality.
[21 CFR 211.198]." |
Medicate Home Care Equipment
Farmington, MO / 12.07.02 |
|
"Failure to have written procedures for handling all
written and oral complaints regarding your drug products as required
by 21 C.F.R. § 211.198." |
Furness Medical Inc.
Palatine, Illinois / 25.07.02 |
|
"Failure to determine a need for an investigation and
failure to conduct investigations into complaints that
pertain to released drug products [21 CFR 211.198].
For example, there is no complaint evaluation to determine
quality problems nor are the individuals taking these
complaints trained to evaluate complaints that may indicate
quality problems." |
COATS Aloe International, Inc. ;
Garland, Texas / 01.05.01 |
|
"There is no documentation of a complaint received
regarding released product [21 CFR 211.198(b)]." |
American Home Health Care Company;
Sioux City, IA / 27.08.01 |
|
"There is no complaint file, nor are appropriate
investigations of complaints conducted [21 CFR 211.198].
The lack of adequate control over your repacking operation has
led to numerous complaints (Medwatch reports) including:
mislabeled drug products; lots with multiple expiration dates; poor
blister pack seals; no package insert or the wrong insert; the lack
of an Rx legend; and the wrong drug in the unit dose containers.
These complaints generated two recalls by your firm in the
past year, both of which were undocumented and
inadequately handled." |
TYA Pharmaceuticals
Tallahassee. FL / 06.08.02 |
