FDA 483 - MedPark Pharmacy, LLC - March 10, 2017

This FDA Form 483 was issued to MedPark Pharmacy, LLC, located at 2002 Medical Parkway, Sajak Pavilion Suite 170, Annapolis, MD 21401. The firm is a producer of sterile and non-sterile drug products. The inspection was conducted on 01/09/2017, 01/11/2017, 01/24/2017, 03/09/2017, and 03/10/2017.

Four observations were noted:

1. **Lack of sterility assurance for prepared sterile human and veterinary drugs:** Drug products and components made from non-sterile materials and sterilized by (b)(4) lacked adequate (b)(4) to ensure sterility. The (b)(4) process was qualitative ("pass" or "fail"). Additionally, (b)(4) vial packs were opened in an unclassified room and handled without consistent glove use. Plastic container closures for eye drops were opened (b)(4), and if not used, were (b)(4) and stored in an unclassified environment for (b)(4) before discard. This is a repeat observation.

2. **Deficient environmental conditions in aseptic processing areas:** Sterile drug preparation was conducted (b)(4) by an (b)(4) located within an unclassified room open