FDA 483 - Promise Pharmacy, LLC - October 25, 2018

This FDA Form 483, issued to Mipal (Amy) Patel, Pharmacist-In-Charge at Promise Pharmacy, LLC, a producer of sterile and non-sterile products located at 31818 Us Highway 19 N, Palm Harbor, FL, details observations from an inspection conducted between October 15-25, 2018.

**Key Observations:**

1. **Microbiological Contamination Prevention:** Procedures to prevent microbiological contamination of sterile drug products were inadequate. Specific instances included an operator blocking HEPA filtered air and not moving slowly in the ISO 5 environment during Bremelanotide production, and an operator not wearing a beard cover during HCG Injectable production. 2. **Quality Control Unit Deficiencies:** The quality control unit lacked responsibility for approving/rejecting procedures impacting drug product quality. The firm did not visually examine finished drug products before dispensing, leading to observed particulates in distributed Prednisolone and Gatifloxacin Ophthalmic Solution. 3. **Contamination Prevention in Facility Design:** The flow of materials and the environment were not designed to prevent contamination. The sterile non-hazardous production environment did not meet ISO 5 standards due to incomplete HEPA filter coverage, lack of full pressure differential assessment, unperformed smoke studies throughout the room, and a non-classified pass-through from the ISO 8 Prep room to the ISO 5 sterile environment. Additionally, partially stoppered vials were