FDA 483 - Barclay Lake & Pillai Specialty Pharmacy PLLC - December 20, 2016

This FDA Form 483 details numerous violations observed during inspections on November 27, 2016, and December 14, 2016, concerning the sterile production of Meta PT Eye Drops Solution (Phenylephrine HCl 2.5%, Tropicamide 1% Ophthalmic Liquid Solution) and other sterile drug products.

Key observations include: - **Microbiological Contamination Prevention:** Procedures are not established or followed. During sterile filling, the Laminar Air Flow Hood (LAFH) sash was fully open, obstructing airflow. Pharmacists placed hands over open vials, blocking HEPA airflow. A lint-free wipe obstructed the LAFH air intake. Gloves were sprayed with sterile alcohol but not allowed to dry. - **Media Fill Simulation:** Media fill procedures do not simulate actual production, lacking critical steps and using smaller batch sizes than typical production. - **Sterility Testing:** Sterility testing was not consistently performed or documented for Meta PT Eye Drops Solution. - **Facility Design and Maintenance:** The cleanroom design is inadequate, with grilles directly connecting the ISO 7 cleanroom to an unclassified area, posing a risk of backflow. Cleaning procedures for the ISO 7 cleanroom and ISO 5 LAFH were not followed, specifically regarding disinfectant dwell times. - **LAFH Certification:** ISO 5 LAFH certification is not performed under dynamic conditions, and airflow patterns are not documented via video. -