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

This FDA Form 483 details observations from an inspection of Promise Pharmacy, LLC, a producer of sterile and non-sterile products, located at 31818 US Highway 19 N, Palm Harbor, FL. The inspection, conducted from October 15-25, 2018, by Investigator Jennifer L. Huntington, identified eight observations.

**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, not moving slowly in an ISO 5 environment, and not wearing a beard cover during sterile product production. 2. **Quality Control Unit Responsibility:** The quality control unit lacked responsibility for approving and rejecting procedures impacting drug product quality. The firm did not perform visual examinations of finished drug products, leading to particulates observed in Prednisolone and Gatifloxacin Ophthalmic Solution, with some dispensed. 3. **Contamination Prevention in Facility Design:** The flow of materials and the environment for sterile, non-hazardous drug production were not designed to prevent contamination. Issues included incomplete HEPA filter coverage, lack of full pressure differential assessment, unperformed smoke studies throughout the entire room, a non-classified opening from an ISO 8 to an ISO 5 environment, and transfer of partially stoppered vials under a light fixture without a HEPA filter. 4. **Microbiological Testing:** Bat