FDA 483 - Clark Professional Pharmacy, LLC - January 29, 2016

On January 29, 2016, the FDA issued a Form 483 to Clark Professional Pharmacy, LLC, a producer of sterile drug products located at 3280 Washtenaw Avenue, Ann Arbor, MI 48104. The inspection, conducted from January 12-29, 2016, by Emily J. Orban and Abuzar Shamim, identified eight observations regarding the facility's sterile drug product manufacturing practices.

Key observations include:

1. **Lack of validated aseptic processing procedures:** Process simulations (media fills) were not representative of worst-case conditions, gloved hands were not consistently sanitized, the autoclave used for terminal sterilization lacked validation documentation, and bioburden of non-sterile components was not evaluated. 2. **Inadequate personnel gowning:** Operators performing aseptic operations in the "ISO 5" glove box wore non-sterile protective gowns and face masks. 3. **Deficient cleaning and disinfection of aseptic areas:** Non-sterile disposable wipes were used in the "ISO 5" glove box, and not all sanitizers and cleaning agents used in classified areas were sterile. 4. **Inadequate environmental monitoring:** Non-viable and viable particulate/air monitoring were performed only once every six months, viable surface monitoring once per week, and incubators for environmental samples lacked qualification data and proper temperature control/justification. 5.