FDA 483 - Pensacola Apothecary, Inc. DBA Everwell Specialty Pharmacy - August 31, 2016

On August 22-26, 29, 31, 2016, the FDA inspected Pensacola Apothecary, Inc. DBA Everwell Specialty Pharmacy, FEI 3005630265, located at 6506 N. Davis Highway, Pensacola, FL 32504. The firm produces sterile and non-sterile drug products. The inspection resulted in four observations.

Observation 1 noted improper gowning apparel storage, specifically gowns for aseptic production stored near a sink in the anteroom, risking contamination from splashes during handwashing.

Observation 2 identified a failure to disinfect equipment, materials, and/or supplies before entering aseptic processing areas. During the production of Methylcobalamin Lot 08242016@10, the inside surface of the ISO5 unit was not sanitized prior to use, despite SOP 5.2.1 requiring cleaning of aseptic production work surfaces.

Observation 3 cited the lack of written procedures for cleaning and maintenance of equipment and utensils used in drug product manufacturing. The Cleaning And Maintenance of the Non-Sterile Compounding Area SOP 4.15 has not been validated to ensure removal of residual product and sanitizing agents, and to prevent cross-contamination between batches.

Observation 4 indicated the absence of written production and process controls to assure drug product identity, strength, quality, and purity. Specifically, mixing instructions, such as