National Chemical Laboratories – FDA Warning Letter, May 26, 2023

On November 8, 2023, the FDA issued Warning Letter #662110 to National Chemical Laboratories, FEI 1000071237, following an inspection from May 22-26, 2023. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals (21 CFR parts 210 and 211), rendering their drug products adulterated.

Key violations include: 1. **Failure to validate component supplier test analyses (21 CFR 211.84(d)(2))**: The firm did not provide documentation of testing for benzalkonium chloride (BZK) used in OTC topical drug products, relying solely on supplier Certificates of Analysis (COA) without establishing reliability. The firm's response to create a supplier qualification program was deemed inadequate due to insufficient detail and lack of retrospective identity testing. 2. **Quality Control Unit (QU) failure to ensure CGMP compliance (21 CFR 211.22)**: The QU provided inadequate oversight, failing to ensure robust procedures, proper oversight throughout operations, complete batch reviews, approval of investigations, and adequate stability studies. The firm's response to implement new procedures and training was insufficient, lacking detail on how oversight would improve and failing to assess the impact of past insufficient oversight on product quality. Cleaning validation was also deficient, lacking testing