Bentley Laboratories LLC

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. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)).

Passage 3

Your firm failed to ensure that components were suitable for use in manufacturing your OTC **(b)(4)** drug products. For example, you did not perform adequate identity testing on each shipment of each lot of incoming components (e.g., **(b)(4)**). Additionally, you relied on your suppliers’ certificates of analysis (COA) without establishing the reliability of each of your component suppliers’ test analyses at appropriate intervals.

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)).