FDA 483 - The Medicine Shoppe Pharmacy - March 16, 2020

The FDA Form 483 details multiple critical deficiencies at a facility producing ophthalmic Cyclosporin/Coconut Oil 2% eye drops for veterinary use.

A primary concern is the inadequate sterilization process. On March 10, 2020, ophthalmic Cyclosporin/Coconut Oil 2% eye drops (lot (b)(4), Rx (b)(6)) were produced without utilizing a sterile (b)(4), and the containers/closures were not sterilized. The firm's Pharmacist admitted to not using a sterile (b)(4) for any sterile drug products.

Significant environmental control issues were noted. Dead ants and cockroaches were observed in the general production area and near the (b)(4) hood where sterile and non-sterile products are made. Aseptic processing was performed outside an ISO 5 classified area, specifically in an unclassified (b)(4) hood lacking HEPA filters, instead using household air filters prone to shedding particulates. The (b)(4) hoods were cluttered with unclean/stained equipment and brown stains. The facility design was deemed inadequate for sterile production, featuring two exit doors to the parking lot, a sink adjacent to the (b)(4) hood, a kitchen dishwasher, and bulk drug substances stored in cardboard boxes. Differential pressure was not monitored. Unsealed, loose, cracked, and stained ceiling tiles were present in the production area.

Personnel engaged in aseptic processing exhibited poor gowning practices, with