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)).
During the inspection, our investigator observed that your quality unit (QU) lacks adequate oversight for the manufacture of your OTC [redacted] drug products. For example:
- Your QU failed to review entire batch records, including raw data and calculations for accuracy, before making appropriate release determination.
- Your batch records were pre-printed as “approved” indicating the assay results were in specification, even before these values are recorded.
- Label review and line clearance were not performed and documented in batch production and control records.