Wedgewood Village Pharmacy, LLC – FDA 483, Feb 11, 2013

The FDA inspection of a facility compounding human and veterinary sterile drugs revealed multiple critical deficiencies across personnel practices, environmental controls, quality systems, and manufacturing processes.

**Personnel and Environmental Control Issues:** * **Aseptic Technique Violations:** Observed items (IV seals, IV bags) hanging in the ISO-5 horizontal laminar flow (HLF) hood, potentially blocking unidirectional airflow. A technician was seen leaning into the ISO-5 HLF hood directly over open containers, exiting the ISO-6 room multiple times during operations, and manipulating paper/pen with gloved hands without re-sanitizing before returning to the hood. * **Inadequate Gowning:** Gowning procedures left neck and feet/shoes exposed. Technicians were observed touching sterile coveralls to the ground during donning. * **Contamination Risks:** Personal items (cell phone, headphones) were brought into cleanrooms and touched critical surfaces. * **Lack of Sanitization:** Materials were not routinely sanitized immediately before entering ISO-6 rooms, ISO-5 HLF hoods, or ISO-5 biosafety cabinets. * **Documentation Failure:** A product leak during sterile filling was not documented in the batch log. * **Gowning Area Deficiencies:** No mirrors were present in ISO-7 gowning areas to ensure proper bouffant cap donning.

**Quality System and Manufacturing Deficiencies:** * **Lack of Sterility/Endotoxin Testing:** Sterile veterinary