FDA WARNING_LETTER - Apothecary Pharma LLC - May 15, 2025

Apothecary Pharma, LLC received an FDA Warning Letter (WL # 717972) on December 1, 2025, following an inspection from May 12-15, 2025, at their Cary, NC facility. The inspection revealed serious deficiencies concerning drug products produced as an outsourcing facility under Section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA).

Key violations included the failure to meet Section 503B conditions, specifically inadequate product labeling (missing ingredient lists, adverse event reporting information, and directions for use) and insufficient adverse event reporting procedures. Consequently, these drug products did not qualify for exemptions from FDA approval, adequate directions for use, and Drug Supply Chain Security Act requirements.

Furthermore, drug products intended to be sterile were deemed adulterated under FDCA sections 501(a)(2)(A) and 501(a)(2)(B) due to insanitary conditions and significant Current Good Manufacturing Practice (CGMP) violations. These included operators blocking critical airflow, improper aseptic techniques, inadequate environmental controls (e.g., rusty equipment, lack of disinfection), and failures in quality control, personnel gowning, equipment maintenance, and batch record preparation. The company also introduced unapproved new drug products and misbranded products lacking adequate directions for use, violating FDCA sections 505(a) and 502(f)(1).

While the firm ceased sterile drug production on May 12, 2025, and provided a response, the FDA found many proposed corrective actions deficient, lacking adequate documentation, retrospective reviews, root cause analyses, and evidence of implementation effectiveness. The FDA strongly recommends a comprehensive third-party assessment of all operations to ensure sustained CGMP compliance. Apothecary Pharma must notify the FDA within 15 working days with specific steps taken to address all violations and prevent recurrence.