# FDA 483 - Edge Pharma, LLC - November 30, 2021

Source: https://www.globalkeysolutions.net/records/483/edge-pharma-llc/a417baff-34f4-4b52-a046-215a936059c1

> FDA 483 for Edge Pharma, LLC on November 30, 2021. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Edge Pharma, LLC
- Inspection Date: 2021-11-30
- Product Type: drugs
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: Edge Pharma, LLC, an outsourcing facility in Colchester, VT, was cited with 13 observations during an FDA inspection from September to November 2021. The inspection revealed significant deficiencies across multiple areas, including facility maintenance, environmental control, quality control unit procedures, and investigation practices for discrepancies, OOS results, and customer complaints. These issues indicate a systemic failure to maintain a state of control and ensure the quality and sterility of drug products.

## Related Documents

- [483 - 2020-03-30](https://www.globalkeysolutions.net/records/483/edge-pharma-llc/56469f38-6722-444f-8a91-e96ca4a3f211)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/erik-w-koester/2bbab081-6783-40a1-83c1-b219bde22bd1)
- [Senior Consumer Safety Officer - Pharmaceutical Quality](https://www.globalkeysolutions.net/people/sean-r-marcsisin/45c910a9-9019-4419-9af8-b1c9f3b1e976)

Company: https://www.globalkeysolutions.net/companies/edge-pharma-llc/fe37306d-c345-48d8-8522-6551293f4d70

Office: https://www.globalkeysolutions.net/offices/fda-district-office-stoneham-massachusetts/1daceb4f-4057-46cf-af02-d4ccde44dcc7