FDA 483 - Wedgewood Connect, LLC - November 17, 2023

The FDA Form 483 details numerous deficiencies at an outsourcing facility producing sterile human and animal drug products.

**Facility and Operations:** The facility operates ISO-5 and ISO-7 aseptic processing areas, including Biological Safety Cabinets (BSCs) and Laminar Airflow Hoods (LAFs). It handles both hazardous (HD) and non-hazardous (NHD) drug products.

**Violations and Observations:** * **Investigations:** Inadequate investigations for unexplained discrepancies, environmental/personnel monitoring excursions (ISO-5 and ISO-7 action limits), and a turbid media fill (OOS00041, lot# (b)(4)) which lacked microorganism identification. Complaint investigations did not evaluate retain samples. * **Aseptic Processing & Environmental Control:** Deficiencies in cleaning/disinfecting systems for aseptic areas. Disinfectant efficacy studies for (b)(4) and (b)(4) solutions were not performed. Environmental monitoring system deficiencies include unsupported surface sampling locations in ISO-5 areas, improperly pointed non-viable particle monitoring probes in ISO-5 BSCs/LAFs and ISO-7 cleanrooms (rooms 120, 121), and insufficient viable microorganism testing in ISO-7 rooms (only (b)(4) required). * **Sterilization & Equipment:** Requalification of the (b)(4) Sterilization Process (Equipment ID# E-0832-