FDA 483 - Family Pharmacy of Statesville - March 11, 2022

The FDA Form 483 details observations from an inspection, highlighting deficiencies in facility operations, aseptic processing, and quality control. The facility's material flow was poor. During compounding of Hydromorphone 1 mg/mL infusion lot #528, a pharmacy technician failed to wipe down the (b)(4) and supplies, and the sterile (b)(4) bottle, with sterile (b)(4) prior to introduction into the ISO 5 BSC. Disinfectant contact time and coverage were insufficient; a sporicidal agent requiring (b)(4) contact time was left to dry while other cleaning occurred.

Media fills did not adequately simulate aseptic production, failing to incorporate worst-case conditions. A Hydromorphone media fill used (b)(4) bags for a total batch size of (b)(4), while the highest volume for this compound is (b)(4). The prescription laboratory room, classified as ISO 8, lacked a HEPA filter, where (b)(4) glassware for sterile processing was stored. Cycle parameters for (b)(4) of materials were not verified with endotoxin indicators.

Smoke studies under dynamic conditions were inadequate, with no equipment or supplies present in the ISO 5 BSC, and worst-case scenarios were not simulated. The ISO 7 cleanroom was certified with both ISO 5 BSCs on, but subsequent operations used only (b)(4) hood, potentially impacting airflow. Non-micro