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# 8 Repeat QS Violations at Edge Biologicals
- URL: https://www.fdaweb.com/8-repeat-qs-violations-at-edge-biologicals/
- Published: 2023-07-19T12:00:00.000Z
- Updated: 2026-09-14T18:45:12.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5154906

A 3/20-4/4 FDA inspection at Edge Biologicals in Memphis, TN, found eight repeat violations in the firm’s manufacturing of Class 1 and 2 *in vitro* diagnostics for medical applications. A 6/27 Warning Letter says the devices are adulterated due to violations of the current good manufacturing practice requirements of the Quality System regulation. The letter says the specific violations were:

- failing to validate a process whose results cannot be fully verified by subsequent inspection and test according to established procedures;
- failing to adequately establish procedures for corrective and preventive actions;
- failing to adequately establish procedures and maintain requirements that must be met by suppliers, contractors, and consultants;
- failing to maintain a device master record;
- failing to adequately establish procedures to control environmental conditions;
- failing to establish procedures for acceptance activities;
- failing to conduct quality audits to determine whether the quality system activities and results comply with quality system procedures; and
- failing to ensure that personnel have the necessary training and experience to perform their jobs.

The letter says all eight inspection observations were repeated from inspections in 2015 or 2018 and/or from a 2018 Warning Letter.

Edge was told to take prompt action to correct the violations and to respond with a list of specific steps it has taken to address the violations and prevent their recurrence, with documentation of the corrections or corrective actions and a schedule for completing the corrections.

FDA asked that Edge submit on a schedule set by the agency certification by an outside expert consultant that he or she has conducted an audit of the firm’s manufacturing and quality assurance systems relative to the requirements of the Quality System regulation, with a copy of the consultant’s report and certification by the Edge CEO that he or she has reviewed the consultant’s report and that the firm has initiated or completed all corrections called for in the report.