FDA 483 - Vita Pharmacy, LLC dba Talon Compounding Pharmacy - October 06, 2021

This FDA Form 483 documents observations from an inspection of a pharmaceutical compounding facility. The facility's design was found to allow poor quality air into higher classified areas. Specifically, there is no HEPA filter coverage for a (b) (4) in a cleanroom connecting a non-classified area to ISO 7 classified cleanrooms containing (b) (4) LAFU, a repeat observation. (b) (4) doors lack safeguards to detect and notify of differential pressure changes, and there are no interlocking mechanisms to prevent (b) (4) or other electronic monitoring systems for differential pressure.

The area outside the modular cleanroom, identified as ISO Class 8, was not adequately controlled or monitored. This area is used for storage, containing (b) (4) and (b) (4), and has a doorway to the non-sterile hazardous drug processing area. A scale for weighing (b) (4) drug components is located approximately 3 feet from an unrestricted doorway leading into this alleged ISO 8 area. Furthermore, ISO-5 classified areas were not certified under dynamic conditions. The firm also handled hazardous drug products without adequate containment, segregation, or cleaning of work surfaces and utensils, leading to potential cross-contamination.