FDA 483 - Barclay, Luke, & Pillai Specialty Pharmacy, PLLC - December 14, 2018

This FDA Form 483 was issued to Sean M. Barclay, Owner of Barclay, Luke, & Pillai Specialty Pharmacy, PLLC, located at 8352 W Warm Springs Rd Ste 120, Las Vegas, NV 89113-3629. The inspection, conducted from November 27, 2018, to December 14, 2018, identified eleven observations regarding the firm's production of sterile and non-sterile drugs.

Key observations include: 1. **Inadequate Microbiological Contamination Prevention:** Procedures for preventing microbiological contamination of sterile drug products are not established, written, or followed. Specifically, the firm's [(b)(4)] test results for Meta PT Eye Drops and Testosterone Cypionate were lower than recommended, indicating potential issues with the sterilization process. 2. **Deficient Environmental Monitoring:** The firm does not perform environmental and personnel monitoring during sterile drug production, only conducting it on a [(b)(4)] basis with cleanroom certifications. ISO 7 cleanrooms, ISO 7 anteroom, and ISO 5 laminar flow hood certifications were not performed [(b)(4)] as required, with the last certification on May 8, 2018. 3. **Lack of HEPA Filter:** Sterile pellets (Testosterone, Estradiol, Progesterone, Naltrexone) are produced and packed in an