21 CFR 211.198 - Complaint Warning Letters in Detail

GMP News No. 240

GMP News

24 September 2002

21 CFR 211.198
Complaint Warning Letters in Detail

We have evaluated the FDA Warning Letters (January 2001 - August 2002) with regard to deviations in complaint handling. This analysis enables you to see at a glance which deficiencies have been cited in detail.

Quotation from Warning Letter

Firm / Date

"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 March 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 April 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 April 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 August 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 August 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 November 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 January 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 July 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 July 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 May 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 August 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 August 02


In 2001 and in the first 8 months of 2002, a total of 12 Warning Letters quoted deviations regarding 21 CFR 211.198 (complaint files). The greatest part of the deviations concerns the lack of written procedures on complaint handling (6 of 8 Warning Letters in 2001 and 3 of 4 in 2002).

What is also criticised is the way in which complaints are handled, like e.g.:

  • missing documentation of complaints received
  • missing evaluation of complaints
  • the personnel is not trained to evaluate complaints
  • no investigation of quality problems despite a great number of complaints and recalls

Author: Dr Gerhard Becker, CONCEPT HEIDELBERG

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