FDA WARNING_LETTER - Analytical Food Laboratories Inc. - May 17, 2024

The FDA inspected Analytical Food Laboratories, Inc. in Grand Prairie, Texas, from May 7-17, 2024, identifying significant Current Good Manufacturing Practice (CGMP) violations for finished pharmaceuticals, rendering tested drug products adulterated.

Key violations include: 1. **Failure to establish and follow required laboratory control mechanisms (21 CFR 211.160(a) and 211.160(b)):** * **Lack of method validation:** Analytical methods for OTC drug products (e.g., (b)(4) oral solution, (b)(4) tablets) were not validated, and written procedures for assay methods were absent. * **Inadequate system suitability:** HPLC analyses lacked appropriate system suitability determination per USP <621>. * **Inadequate growth promotion testing:** Microbiological media growth promotion tests (e.g., batches 06-19-23-3, 06-19-23-5) used only one indicator microorganism instead of all required challenge microorganisms per USP <61>. * The firm's May 31, 2024, response was inadequate, lacking sufficient detail on corrective actions, complete validation protocols, study results, and a retrospective risk assessment for affected drug samples.

2. **Quality control unit failure (21 CFR 211.