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

Source: https://www.keypedia.com/records/483/edge-pharma-llc/7e3b41a5-7c7d-4daf-a4b0-55694af95640

> 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
- Summary: An FDA inspection of Edge Pharma, LLC, an outsourcing facility in Colchester, VT, conducted from March 4-30, 2020, revealed 14 observations. William Chattoff, CEO, was issued the report.

Key violations include:

**Quality System and Manufacturing Issues:**
*   **Inadequate Investigations (Observation 1):** Failure to thoroughly investigate unexplained discrepancies, batch failures, and customer complaints. This includes recalled sterile drug products (e.g., mislabeled Neostigmine, Bevacizumab with subvisible particles, sub-potent Dibutyl Squaric Acid), presumptive sterility positives (e.g., Cefuroxime PF, Phenylephrine HCl, Media Fill contaminants, Cefuroxime PF), and 9 customer complaints regarding leaking/broken container closure systems. Previous inspections in 2018 also noted inadequate investigations.
*   **Environmental Monitoring Deficiencies (Observation 2):** Inadequate environmental monitoring practices in classified and aseptic processing areas. This includes failure to investigate environmental excursions with microbial species identification and perform corrective actions (e.g., mold in ISO-8 and ISO-7 rooms), incomplete identification of objectionable microorganisms (24 out of 294 mold/fungus recoveries not identified to species level), failure to identify/investigate all ISO-5 microbial recoveries from operator sleeves, unscientific sampling locations for laminar flow hoods, lack of scientific rationale for alert/action levels,

## Related Documents

- [483 - 2014-08-20](https://www.keypedia.com/records/483/edge-pharma-llc/3aa88b51-af31-4317-83a0-521873c90b36)
- [WARNING_LETTER - 2014-08-20](https://www.keypedia.com/records/warning_letter/edge-pharma-llc/cde15fa9-55de-4c92-83de-905476745173)
- [483 - 2017-01-20](https://www.keypedia.com/records/483/edge-pharma-llc/ae76219a-3c7f-4411-820c-d17398de7152)
- [483 - 2018-03-08](https://www.keypedia.com/records/483/edge-pharma-llc/25a2ac61-dd34-419d-a01d-65d70b200dda)
- [483 - 2021-11-30](https://www.keypedia.com/records/483/edge-pharma-llc/1b48eef5-17aa-4245-ac4b-2f43519922c6)

## Related Officers

- [Jonah S. Uteffringle](https://www.keypedia.com/people/jonah-s-uteffringle/01882c12-37f9-4db0-97a5-0c76e8e4fd38)
- [Investigator](https://www.keypedia.com/people/erik-w-koester/2bbab081-6783-40a1-83c1-b219bde22bd1)
- [Jonah S. Utterfilge](https://www.keypedia.com/people/jonah-s-utterfilge/36282887-3f85-4aca-a8be-14aa5e308332)
- [John P. Mittler](https://www.keypedia.com/people/john-p-mittler/40d166eb-2825-4f9b-9aef-a03936cf4e8c)
- [Regional Manager](https://www.keypedia.com/people/jonah-s-ufferfilge/6bcd2028-9aca-4704-bd7b-c835874fad9d)

Company: https://www.keypedia.com/companies/edge-pharma-llc/8e1a2d92-d72f-4102-8b1a-e37e96a75b69