FDA WARNING_LETTER - Allay Pharmaceuticals, LLC - May 15, 2020

The FDA inspected Allay Pharmaceuticals, LLC, from May 5-15, 2020, identifying significant CGMP violations for finished pharmaceuticals, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B). Specifically, their (b)(4) tablets were also adulterated under 21 U.S.C. 351(b) for failing to meet compendial standards. The products, containing (b)(4), are classified as drugs and biological products.

Violations included: 1. **Failure to establish adequate written procedures for production and process control (21 CFR 211.100(a)):** Inadequate validation of (b)(4) tablet manufacturing processes, lack of blend homogeneity data, and sub-potent active ingredient results in FDA samples. The firm's proposed concurrent validation and OOS investigation were deemed inadequate. 2. **Failure to thoroughly investigate discrepancies or failures (21 CFR 211.192):** Inadequate investigation of OOS assay results for (b)(4) tablets, inappropriate active ingredient assay specifications (below USP standards), and failure to investigate previously released lots. 3. **Inadequate stability testing program (21 CFR 211.166(a)):** Lack of long-term stability data for commercial validation batches using a new API supplier and inconsistent disintegration testing