FDA Hits Drug Outsourcing Facility with 5-page 483

An 8/2021 FDA outsourcing facility inspection of Eagle Pharmacy (Hoover, AL) has led to a five-page Form FDA 483 that cited several GMP deficiencies. For example, the agency said aseptic processing areas are deficient regarding the system for monitoring environmental conditions. Specifically, the 483 says environmental surface sampling conducted in the vial filling room is not taken in the most critical areas where aseptic manipulation occurs.

The inspection also cited the facility’s procedures designed to prevent microbiological contamination because they did not include adequate validation of the aseptic and sterilization process. Additionally, the inspection found that laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that the drug products conform to appropriate standards of identity, strength, quality and purity.