FDA 483 - MedPark Pharmacy, LLC - May 23, 2016

This FDA Form 483 was issued to MedPark Pharmacy, located at 2002 Medical Parkway, Suite 170, Sajak Pavillion, Annapolis, MD 21401, a producer of sterile and non-sterile drug products. The inspection occurred on May 9-10, 2016, and May 23, 2016, with the report issued to Joan M. Phillips, Pharmacist, on May 23, 2016.

Five observations were noted:

1. **Inadequate Product Testing and Release:** The firm does not consistently test sterile and non-sterile drug batches for conformance to final specifications, identity, and strength before release. A Trimix batch recall on May 3, 2016, due to Alprostadil failing potency, exemplifies this. 2. **Insufficient Sterility Testing:** Batches of sterile drug products are not consistently tested for objectionable microorganisms. Despite being rendered sterile by a specific process, products are not consistently checked for contamination prior to distribution. Sterility testing has been limited since sterile compounding began in March 2016. 3. **Lack of Depyrogenation for Glassware:** The firm does not use depyrogenated glassware for sterile drug product preparation and lacks equipment or a validated process for depyrogenation. Glassware is cleaned by a specific process, but not depy