FDA WARNING_LETTER - Norland, A Cooper Surgical Company - September 13, 2011

On January 4, 2012, the FDA issued a Warning Letter to Norland, A Cooper Surgical Company, following an inspection from August 30 to September 13, 2011. The inspection found that the firm's bone densitometers, classified as medical devices, were adulterated under 21 U.S.C. § 351(h) due to non-conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820).

Key violations included: 1. **Failure to establish adequate procedures for design changes (21 CFR 820.30(i))**: An Engineering Change Notice (ECN) was not completed for a procedure distributed to customers to address a software defect causing improper archiving of scan results. There was also no documentation of verification or validation for this procedure. 2. **Failure to adequately review and evaluate complaints (21 CFR 820.198(b))**: Five of eight complaints reviewed were not evaluated to determine if an investigation was necessary. 3. **Failure to establish adequate procedures for receiving, reviewing, and evaluating complaints (21 CFR 820.198(a))**: Product Complaint Reports 683 and 1129, which reported problems with multiple devices, were not processed as separate complaints,