FDA 483 - Westlab Pharmacy, Inc. dba Westlab Pharmacy - October 05, 2021

This FDA Form 483 was issued to Westlab Pharmacy Inc. dba Westlab Pharmacy, a producer of sterile and non-sterile drug products, located at 4410 W. Newberry Rd., Gainesville, FL, following an inspection from September 27, 2021, to October 5, 2021. The report details eight observations indicating objectionable conditions and practices.

Key violations include: 1. **Vermin in Production Area:** A large dead insect (wasp) was found in the ceiling light fixture directly above the ISO-5 laminar airflow hood in the ISO-5 Cleanroom, and similar insects were in ceiling light fixtures in the ISO-8 Anteroom. 2. **Non-Microbial Contamination:** Brown stains were observed on the HEPA filter within the ISO-5 laminar airflow hood. A non-sterile suite's equipment had a taped opening that could not be cleaned. Dust accumulated on a fire sprinkler in the non-sterile suite. 3. **Inadequate Environmental Monitoring:** No environmental monitoring (viable/non-viable, surface, personnel) was conducted during or immediately after sterile compounding. 4. **Deficient Media Fills:** Media fills did not simulate worst-case aseptic production, specifically failing to incorporate open sterile dropper containers used for ophthalmic products, instead simulating a closed system. 5. **Aseptic Technique Violations:** A