FDA WARNING_LETTER - Duro-Med Industries - April 02, 2008

On March 31, 2008, an FDA inspection of a Jesup, GA firm manufacturing disposable and reusable hot and cold compresses revealed significant violations of the Quality System (QS) regulation (21 CFR Part 820), rendering their devices adulterated under the Federal Food, Drug, and Cosmetic Act.

Key deficiencies included: 1. **Quality System:** Failure of management to implement and maintain an adequate and effective quality system, evidenced by unaddressed corrective and preventive actions (CAPAs) from April 2007 audits due to resource limitations. 2. **Process Validation:** Lack of documented validation for sealing parameters on the Water Bag Machine, Vertical Packaging Machine, and Emplex Rotary Band Heat Sealers. 3. **Complaint Handling:** Failure to investigate complaints involving device failures, specifically a burned cornea (Complaint #2007-11-001) and leaking cold packs (Complaint #2007-09-009), with no follow-up or proper closure. 4. **CAPA Implementation:** Failure to implement several CAPAs (2007-CAPA-002 through 005) initiated after an April 2007 audit. 5. **Device Master Record (DMR):** Absence of documented specifications and acceptance criteria for manufactured devices, leading to no assurance of finished device conformity. 6. **Nonconforming Product Control:** Lack of