Edge Biologicals Inc.

Warning LetterOpen

Walter C. Edge Jr. President Edge Biologicals Inc. 635 North 3rd Street Memphis , TN 38107 United StatesFEI 1049818Issued Jun 27, 2023Division of Medical Device and Radiological Health Operations Central

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Violations5

Issue DateJun 27, 2023

Product TypeMedical Devices

StatusOpen

Letter Details

Firm: Edge Biologicals Inc.
Location: Walter C. Edge Jr. President Edge Biologicals Inc. 635 North 3rd Street Memphis , TN 38107 United States
FEI Number: 1049818
Country: United States
Issue Date: June 27, 2023
Issuing Office: Division of Medical Device and Radiological Health Operations Central
Product Type: Medical Devices
Status: Open

Summary

Edge Biologicals Inc., a Memphis-based manufacturer of in vitro diagnostic devices, failed to comply with Current Good Manufacturing Practice (CGMP) requirements under the Quality System regulation. During a March-April 2023 inspection, FDA investigators identified critical failures including inadequate validation of cleaning processes for controlled environmental areas used in aseptic processing of culture media and failure to validate sterilization procedures for tubing sets used in aseptic fill operations. These violations rendered the company's Class I and Class II medical devices adulterated, with the sterilization validation failure noted as a repeated observation from a prior inspection.

Edge Biologicals Inc. FDA Warning Letter, June 27, 2023