FDA 483 - Medoz Pharmacy of Polk Inc - August 09, 2019

This FDA Form 483 was issued to Medoz Pharmacy of Polk Inc, a producer of sterile and non-sterile drugs, located at 40230 Highway 27 Ste 100, Davenport, FL 33837-7807. The inspection was conducted from July 30, 2019, to August 9, 2019, and the report was issued to Tushar Palan, MS, RPh, Partial Owner & Pharmacist in Charge.

The inspection revealed 14 observations:

1. **Inadequate Cleaning for Hazardous Drugs:** The firm produced hazardous drugs (Chorionic Gonadotropin and Cyclosporin) on the same day without evidence of cleaning between batches or identifying the ISO 5 BSC used, leading to potential cross-contamination. 2. **Vermin in Production Area:** Numerous dead ants were observed in the clean room (sterile drug production) and non-sterile suite (non-sterile drug production). Household spray was used, and no pest control records were provided. 3. **Vermin Adjacent to Production Area:** Dead spiders, cockroaches, and ants were found in the anteroom, on sterile stopper packaging in an unclassified area, and in hallways leading to the non-sterile suite. Living spiders were also observed. 4. **Dirty ISO 5 Aseptic Processing Areas:** The Bio-Safety Cabinet ISO