FDA WARNING_LETTER - Formology Lab Inc. - September 09, 2022

On March 1, 2023, the FDA issued a Warning Letter to Formology Lab Inc. following an inspection from August 30 to September 9, 2022, at their Chatsworth, California drug manufacturing facility. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations, rendering their drug products adulterated under the FD&C Act.

Key violations include: 1. **Failure to identity test components:** The firm did not test Active Pharmaceutical Ingredients (API) before use, manufacturing and releasing at least (b)(4) drug product batches without prior identity testing. The response was inadequate, lacking implementation timelines, specific testing details, and an impact assessment. 2. **Inadequate production and process controls:** The firm lacked an ongoing program for monitoring process controls, failing to validate manufacturing processes for OTC sunscreen drug products. Additionally, water used for manufacturing was not tested for conductivity and total organic carbon (TOC) to ensure it met USP standards. The provided Master Validation Plan was insufficient, lacking timelines and addressing water testing. 3. **Inadequate quality unit:** The quality unit failed to establish written procedures for critical oversight responsibilities (e.g., investigations, change management, CAPAs, training). The firm also lacked appropriate stability data, with an insufficient number of batches on stability and inadequate investigation of out-of-specification viscosity results for (b)(4) and (b)(4) formula