FDA 483 - Family Pharmacy of Statesville - February 12, 2020

The FDA Form 483 details multiple deficiencies at a facility producing sterile and non-sterile drug products, including those for injection and intrathecal administration.

**Sterile Product Deficiencies:** * **Cleaning and Disinfection:** Sporicidal agents were not used in cleanrooms or ISO 5 aseptic processing areas, and the cleaning log did not indicate their use. Disinfecting agents and wipes used in ISO 5 areas were not sterile; an expired, mislabeled, and reused spray bottle was found. * **Environmental Control:** Viable air sampling in ISO 5 hoods recovered *Staphylococcus spp.* and *Micrococcus/Kocuria spp.* Facility design allowed poor quality air into higher classified areas, with visible dust in an unclassified pass-through to an ISO 7 buffer room and an ISO 7 return air vent lacking HEPA filtration. * **Product Testing:** No endotoxin testing was performed for intrathecal drug products or their non-sterile starting materials/APIs, specifically for morphine sulfate buprenorphine 20 mg/4mg for intrathecal injection lot 01272020@6. * **Aseptic Processing:** Media fills did not adequately simulate aseptic production or incorporate worst-case conditions. * **Hazardous Drug Handling:** Hazardous drugs (e.g., fluorouracil, vancomycin) were produced without adequate containment, segregation, or