FDA 483 - Main Street Family Pharmacy, LLC - June 11, 2013

During an inspection from May 22 to June 11, 2013, the FDA observed 25 violations at Main Street Family Pharmacy, LLC in Newbern, TN, a producer of sterile drug products.

**Key Violations and Observations:**

* **Sterilization Process Validation (Observation 1):** The firm lacked validation for its sterilization processes, including the autoclave (no data, biological indicators, or continuous temperature monitoring), endotoxin and sterility testing (no positive/negative controls), media fills (static conditions, not representative of batch sizes), smoke studies (static conditions, not properly documented), and lyophilization unit. * **Equipment Records and Maintenance (Observations 2, 3, 18):** No equipment cleaning, maintenance, or use logs were maintained for critical equipment like the autoclave and sterility/endotoxin testing unit. Equipment was not cleaned/sanitized at appropriate intervals, evidenced by lack of sporicidal agents, un-disinfected components entering cleanroom, product splatter on HEPA filters and hoods, charred debris on stirrers, oil leak from lyophilization unit motor, and stained workbenches. Routine calibration of equipment like the autoclave gauge and scales was not performed or documented properly. * **Contamination Control (Observations 4, 5, 6, 7, 8, 10, 25):** Vials were stored open to the environment. Employees wore inappropriate attire