During our inspection, our investigator observed specific violations including, but not limited to, the following.
1. Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release (21 CFR 211.165(a)).
For example, multiple batches of Vaporizing Chest Rub and [redacted] failed to meet finished product specifications, including active ingredient content. Despite these failing test results, you shipped these drugs to the United States.
Additionally, your staff informed our investigator that batches are not routinely tested. Instead, your firm re-uses test results from a past batch produced several years ago, and enters those results on certificates of analysis for new batches.
Your brief response indicated that your firm is performing batch testing, but included no raw data or test results.
3. Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards (21 CFR 211.194(a)).That's one way to save on pesky laboratory fees!
You had no records to support the analytical testing results reported on your certificate of analyses. Your firm indicated to our investigator that you document finished product analysis on a pad of paper, transcribe the test results onto a certificate of analysis, and then destroy the piece of paper. There is no assurance that the testing was conducted in the first place, and there is no record that any associated calculations were performed.