2. Your firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products (21 CFR 211.22(a)).
Your quality unit failed to exercise its authority to approve, release, and distribute OTC drug products before all analytical testing was completed and reviewed. In addition, your firm approved and released OTC drug products that did not meet their final specification. For example:
- For [redacted] batches of [redacted], your sales manager was provided with test results from your contract laboratory that were out of specification [redacted] for [redacted] assay. The batches were distributed without the quality unit’s review of the failing test results.
- A batch of [redacted] (Lot [redacted]) was released by your quality unit on August 3, 2017, and was shipped on August 7, 2017, before your firm received the results of assay testing.
In your response, you provided an updated standard operating procedure and the associated training records concerning the release of OTC drug products with inadequate quality oversight. However, your response is inadequate because you have not determined the root cause of this violation.Eh, the assay probably would have shown the material to be in spec anyway... ship it!