ABS Corporation

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).

Passage 2

Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality. Additionally, your firm failed to withhold components from use until sampling, testing, examination, and release by the quality control unit (21 CFR 211.84(d) and 21 CFR 211.84(a)).

Passage 3

You failed to perform adequate identity testing on each shipment and lot of incoming components at high risk of contamination. Additionally, you used expired raw material in the manufacture of drug products before receiving retest results and subsequently released those batches for distribution after the material failed retesting. For example:

Passage 4

Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).