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# Edge Pharma Gets 17-page Form 483
- URL: https://www.fdaweb.com/edge-pharma-gets-17-page-form-483/
- Published: 2020-10-12T12:00:00.000Z
- Updated: 2026-09-14T16:32:10.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147849

A March FDA inspection of Colchester, VT-based Edge Pharma produced a just-released [17-page Form FDA 483](https://www.fda.gov/media/142470/download?ref=fdaweb.com) that cites numerous GMP deficiencies. For example, agency investigators said the firm failed to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed. The inspection also took issue with aseptic processing areas being deficient regarding its system for monitoring environmental conditions. It further said Edge’s environmental monitoring practices of classified and aseptic processing areas do not ensure appropriate levels of environmental cleanliness. Additionally, the agency said test procedures relative to appropriate laboratory testing for sterility are not written and followed.