Sharn, Inc. – FDA Warning Letter, Aug 11, 2011

On December 29, 2011, the FDA issued a Warning Letter to Sharn, Inc. following an inspection from August 10-11, 2011. The inspection found that Sharn, a repacker and relabeler of Class I and Class II medical devices (e.g., Crystaline® II and TempAlert® II Temperature Indicators), was operating in violation of the Federal Food, Drug, and Cosmetic Act.

The devices were deemed adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820). Key violations included: - Failure to establish and maintain adequate procedures for Corrective and Preventive Action (CAPA) (21 CFR 820.100(a)). - Inadequate procedures for receiving, reviewing, and evaluating complaints, including determining reportable events under Medical Device Reporting (MDR) (21 CFR 820.198(a)(3)). - Failure to maintain adequate records of complaint investigations (21 CFR 820.198(e)). - Inadequate procedures for purchasing control (21 CFR 820.50) and acceptance activities (21 CFR 820.80(a)) for all received products. - Failure to control noncon