Warning Letter Cites AFP for GMP Violations

November 4, 2015

FDA noted multiple manufacturing, testing, and labeling violations at American Family Pharmacy’s Indianapolis facility.

FDA has issued a warning letter to American Family Pharmacy (AFP), Indianapolis, IN, for violations of good manufacturing practices observed during a June 22–July 8, 2014 inspection.

The violations included failure to fulfil its registration and listing obligations, failure of a delayed release product (Aspirin Enteric Safety Coated Tablets) to meet compendial specifications for assay, content uniformity, and dissolution.

FDA noted that the company assigned all 81 mg aspirin tablets manufactured over five months to a single lot number, negating the ability to distinguish between lots. The lot was released without quality testing for identity, strength, quality, and purity of the drug product. A similar practice was followed for lots of 500 mg acetaminophen.

In addition, the company failed to establish and follow procedures for receiving, handling, or testing components and drug product containers and closures; failed to establish adequate written procedures for production and process control to assure that manufactured drug products have the identity, strength, quality, and purity they are represented to possess; failed to assure that the expiration dates for the drug products are determined by appropriate stability testing; and failed to establish and follow written procedures to assure correct labeling of drug products.

In branding violations, the immediate container label for aspirin enteric safety coated tablets did not include warnings for Reye’s Syndrome or stomach bleeding. Three products were not listed with FDA.

The company informed FDA that it had ceased operations in May 2014.

In the warning letter, FDA noted that the agency “strongly recommends that if you decide to resume production, you undertake a comprehensive assessment of your operations before you restart manufacturing and distributing any drug products. We also strongly recommend that this comprehensive evaluation is conducted by a qualified third party consultant with relevant manufacturing expertise. “

Source: FDA