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

Source: https://www.keypedia.com/records/483/wedgewood-connect-llc/7755e859-157d-4b49-b7c9-c10d3e7f9055

> FDA 483 for Wedgewood Connect, LLC on November 17, 2023. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Wedgewood Connect, LLC
- Inspection Date: 2023-11-17
- Product Type: Drugs
- Office Name: San Francisco District Office
- Summary: 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-

## Related Documents

- [483 - 2021-12-03](https://www.keypedia.com/records/483/wedgewood-connect-llc/c7cc6b31-beb9-48a1-8899-6adcc3a25f2d)
- [483 - 2018-12-19](https://www.keypedia.com/records/483/wedgewood-connect-llc/9bf23e25-2dd6-4f6f-8404-6b1b89d277ae)
- [UNTITLED_LETTER - 2023-11-17](https://www.keypedia.com/records/untitled_letter/wedgewood-connect-llc/48ee4659-fbc1-4f3a-bac8-182cf65c19f4)
- [UNTITLED_LETTER - 2023-11-09](https://www.keypedia.com/records/untitled_letter/wedgewood-connect-llc/c7b71d6a-971e-480f-9e52-95939c6a80af)
- [145 - 2018-05-29](https://www.keypedia.com/records/145/wedgewood-connect-llc/44a77771-dde4-46ed-bcd3-26323f1114bc)

## Related Officers

- [Regulatory Affairs Specialist](https://www.keypedia.com/people/andrew-le/573464c0-de29-4f64-ab33-62543b7fe719)
- [Consumer Safety Officer](https://www.keypedia.com/people/jeffrey-p-raimondi/7576ca4e-d9e8-4015-9ae6-9498e76058d3)
- [Statistical Science Director](https://www.keypedia.com/people/anney-lin/e1dc45a5-a28f-4636-be13-e9bee6f3bc4e)

Company: https://www.keypedia.com/companies/wedgewood-connect-llc/26eedeaf-d44e-48a5-b4c3-8b28c9b361ff

Office: https://www.keypedia.com/offices/san-francisco-district-office/6f838e9c-aae1-4665-9c46-a51d43be02df