FDA Updates List of Warning Letters

FDA has updated its website to include the latest Warning Letters issued to pharmaceutical companies by the Office of Prescription Drug Promotion and the Center for Drug Evaluation and Research (CDER).

Improper training and a lack of written procedures were among some of the citation trends. Deviations from cGMP in the manufacture of APIs cited by CDER include:

• Failure to use dedicated production areas when performing operations with beta-lactam products.

• Failure to have laboratory records that include complete data derived from all tests conducted to ensure compliance with established specifications and standards.

• Failure to ensure laboratory instrumentation for assuring the quality of APIs is calibrated according to written procedures and an established schedule.

• Failure to have a written procedure to investigate out-of-specification results.

• Failure to ensure proper training.

• Failure to ensure batch production records are prepared for each API and include complete information relating to the production and control of each batch.

• Failure of quality unit to review and approve all appropriate quality related documents.

• Failure of your quality unit to establish written procedures.

• Failure to validate those operations critical to the quality and purity of the API.

Violations in regulations for finished pharmaceuticals include:

• Not thoroughly investigating the failure of a batch to meet its specifications whether or not the batch has already been distributed.

• Not establishing the reliability of the supplier’s analyses through appropriate validation of the supplier’s test results at appropriate intervals.

• Not establishing scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality, and purity.

• Not establishing or following appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile.

Warning Letters issued by the Office of Prescription Drug Promotion in 2012 cite drug manufacturing companies for overstating efficacy of products, misbranding, presenting misleading information, making unsubstantiated claims, and omitting risk information from advertising materials in a variety of media outlets.

A complete list of FDA-issued Warning Letters can be found at FDA.gov.