# FDA 483 - Wedgewood Village Pharmacy, LLC - March 24, 2022

Source: https://www.globalkeysolutions.net/records/483/wedgewood-village-pharmacy-llc/8b721f8b-bf3f-40e6-9db0-4bd064948120

> FDA 483 for Wedgewood Village Pharmacy, LLC on March 24, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Wedgewood Village Pharmacy, LLC
- Inspection Date: 2022-03-24
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Wedgewood Village Pharmacy, LLC in Swedesboro, NJ, a producer of sterile and non-sterile drug products, revealed multiple critical deficiencies. Observations included widespread non-microbial and microbial contamination in production areas, inadequate aseptic processing practices, failed HEPA filters, and vermin infestations in storage areas. These findings indicate a severe lack of control over environmental conditions and manufacturing processes, posing significant risks to drug product quality and patient safety.

## Related Documents

- [483_RESPONSE - 2015-09-30](https://www.globalkeysolutions.net/records/483_response/wedgewood-village-pharmacy-llc/89cbc59b-aba4-4e29-91ff-bfeaf873536a)
- [483 - 2022-03-24](https://www.globalkeysolutions.net/records/483/wedgewood-village-pharmacy-llc/57d11aab-1a1f-41e8-81d3-023bc714582b)
- [483 - 2013-02-11](https://www.globalkeysolutions.net/records/483/wedgewood-village-pharmacy-llc/354a115c-2852-460e-9bfc-0082af794a79)
- [483 - 2015-09-29](https://www.globalkeysolutions.net/records/483/wedgewood-village-pharmacy-llc/14c9b9f5-15ed-463b-b0d5-99aa133e6b2d)
- [WARNING_LETTER - 2013-02-11](https://www.globalkeysolutions.net/records/warning_letter/wedgewood-village-pharmacy-llc/36f5a620-e433-45cd-84b4-17f043bc67f3)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/kristina-l-conroy/d6f2d9e4-f547-4bb2-9531-157b5890fae0)
- [Senior Consumer Safety Officer - Pharmaceutical Quality](https://www.globalkeysolutions.net/people/sean-r-marcsisin/45c910a9-9019-4419-9af8-b1c9f3b1e976)
- [Investigator](https://www.globalkeysolutions.net/people/leanna-m-slarsky/9b79fd53-ec91-42bf-aba4-ab106fee9cbc)

Company: https://www.globalkeysolutions.net/companies/wedgewood-village-pharmacy-llc/06cf5b50-fc20-475b-8be4-11a41985491e

Office: https://www.globalkeysolutions.net/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248