FDA 483 - Apothecary Pharma LLC - May 15, 2025

From May 12-15, 2025, the FDA inspected Apothecary Pharma LLC, an outsourcing facility in Cary, NC, and issued a Form 483 with eight observations to Priyanka Rana, President and Chief Pharmacy Officer.

**Quality Control System Deficiencies:** * **Observation 1:** The Quality Control Unit (QCU) failed to follow written procedures. Specifically, the QCU did not review cleanroom certification reports (ISO 7 and ISO 5) before releasing sterile drug products in 2025, did not ensure all batch records were reviewed for completeness, failed to finalize draft procedures (SOP1002, SOP1011, SOP1012, SOP1014), and did not follow SOP2004 for visual inspection, causing excessive air bubbles. * **Observation 2:** Protective apparel was not worn as necessary to prevent drug product contamination. During Semaglutide Injection 2.5mg/mL production on May 12, 2025, operators had exposed skin (forehead, cheeks) and did not follow SOP0003 Cleanroom Entry and Exit procedures regarding shoe covers, donning order of booties/coveralls, and donning goggles/masks inside the gowning room. Operators also ignored the line of demarcation and one wore a face mask upside down.

**Facility and Buildings Control System Deficiencies:** * **