FDA WARNING_LETTER - Apothecus Pharmaceutical Corp. - April 30, 2019

The FDA inspected Apothecus Pharmaceutical Corp. in Hicksville, NY, from April 15-30, 2019, identifying significant CGMP violations for combination products, rendering them adulterated.

Violations include: 1. **Inadequate Investigation of Discrepancies (21 CFR 211.192):** The firm failed to thoroughly investigate out-of-specification (OOS) results and complaints for VCF vaginal contraceptive foam batches #31560 and #31561, including leakage and illegible codes. Despite acknowledging issues, the investigation was not expanded to other batches, and no market action was initiated for the affected batches as stated during the inspection. 2. **Inadequate Quality Control Unit (21 CFR 211.22(a)):** The Quality Unit (QU) lacked sufficient authority and resources, failing to ensure drug quality, including oversight of stability data. 3. **Insufficient Computer System Controls (21 CFR 211.68(b)):** The HPLC data acquisition system lacked controls to prevent data deletion or unauthorized alteration. The laboratory manager had administrative privileges, data was not backed up, and there was no approved procedure for data security or QU review of audit trails.

Required corrective actions include retrospective reviews of OOS results and HPLC data, remediation of OOS investigation and stability programs, comprehensive assessment of the QU's authority and