# FDA 483 - Edge Pharma, LLC - March 30, 2020

Source: https://www.globalkeysolutions.net/records/483/edge-pharma-llc/56469f38-6722-444f-8a91-e96ca4a3f211

> FDA 483 for Edge Pharma, LLC on March 30, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Edge Pharma, LLC
- Inspection Date: 2020-03-30
- Product Type: drugs
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: Edge Pharma, LLC received a Form 483 citing significant deficiencies across its manufacturing, quality control, and facility operations. Key issues include inadequate investigations into product recalls, sterility failures, and customer complaints, as well as widespread problems with environmental monitoring, aseptic processing, stability testing, and equipment qualification. The report also highlights failures in data integrity, material control, and compliance with adverse event reporting and labeling requirements for an outsourcing facility.

## Related Documents

- [483 - 2021-11-30](https://www.globalkeysolutions.net/records/483/edge-pharma-llc/a417baff-34f4-4b52-a046-215a936059c1)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/erik-w-koester/2bbab081-6783-40a1-83c1-b219bde22bd1)
- [John S Differding](https://www.globalkeysolutions.net/people/john-s-differding/325472ab-4289-4923-9d5e-9bab060d2885)
- [Amir C Saleh](https://www.globalkeysolutions.net/people/amir-c-saleh/16a84b9a-5b0e-4639-bfb2-91d5c07097e9)
- [Arizona Market President](https://www.globalkeysolutions.net/people/john-p-mistler/7b2d423d-46cc-48bd-aa5a-4ae794888060)

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