FDA 483 - Absolute Pharmacy, LLC - April 11, 2016

This FDA Form 483 details significant deficiencies in the manufacturing of sterile drug products. Repeated observations from a previous 483 (11/19/14) and Warning Letter (4/27/15) are noted.

Key violations include inadequate procedures to prevent microbiological contamination. Media fills for qualifying pharmacists in aseptic operations were insufficient, not simulating current or worst-case conditions. Aseptic pharmacists lacked documentation of adequate media fills, and a disqualification/re-qualification program for them was absent. Deficiencies in aseptic technique were observed during a demonstration, including working directly over open vials.

Sterilization processes for Testosterone products and lyophilization for Sermorelin, HCG, Methylcobalamin, and IGF were not validated. Aseptic processing areas lacked adequate environmental monitoring, cleaning/disinfecting procedures, and proper HEPA-filtered air supply.

The firm failed to establish and follow an Out of Specification (OOS) Procedure, evidenced by Quality Related Event Reports for low volume (Cyanocobalamin), sterility failure (Testosterone Cypionate), endotoxin failure (L-Carnitine), and low potency (Methylcobalamin), without an SOP for these reports. Nonconformance procedures (SOP No. 9.0104) were not followed, as seen with particulate in Testosterone Enanthate vials and bursting Ascorbic Acid vials.

Furthermore, there were no written standards for depyrogen