FDA 483 - HV Pharmacy Inc. dba Hunt Valley PharmaLab - August 17, 2018

On August 17, 2018, the FDA issued a Form 483 to HV Pharmacy Inc. dba Hunt Valley PharmaLab in Cockeysville, MD, following an inspection from August 6-17, 2018. The firm is identified as a producer of sterile and non-sterile drugs.

The inspection revealed three observations:

1. **Inadequate Sterilization Cycle Evaluation:** The firm's sterilization cycle parameters for testosterone and estradiol pellets, intended to be sterile, were not adequately evaluated for lethality to resistant microorganisms. Biological indicators were not subjected to the same conditions as the pellets, providing no assurance of the cycle's adequacy. Additionally, there was no documentation assessing the impact of the sterilization process on compressed pellets. Multiple lots of both testosterone and estradiol pellets had been produced and distributed since May 2018 under these conditions.

2. **Compromised Aseptic Technique:** Personnel were observed blocking first-pass air flow during aseptic manipulations. Specifically, on August 8, 2018, an operator placed their hand(s) directly above an uncapped, open vial of Avastin injectable solution while repackaging it into syringes in a Class 100 Laminar Air Flow Workstation, obstructing unidirectional air flow.

3. **Use of Non-Pharmaceutical Grade Components:** The firm used a non-pharmaceutical grade component in the formulation of several non-