FDA WARNING_LETTER - LAR MFG., LLC - September 01, 2015

On December 9, 2015, the FDA issued a Warning Letter to LAR MFG., LLC, following an inspection from August 31 to September 1, 2015. The inspection revealed that the firm's ceramic dental brackets, classified as devices, were adulterated under 21 U.S.C. § 351(h) because their manufacturing, packing, storage, or installation methods did not conform to current Good Manufacturing Practice (cGMP) requirements of the Quality System (QS) regulation, 21 CFR Part 820. The firm's October 5, 2015, response to the FDA 483 was deemed inadequate.

Key violations include: 1. Failure to validate manufacturing processes (e.g., bracket coating) as required by 21 CFR 820.75(a). 2. Failure to establish corrective and preventive action (CAPA) procedures, including analysis, investigation, identification of actions, verification, implementation, dissemination of information, and management review, as required by 21 CFR 820.100(a). 3. Failure to establish procedures for routine calibration, inspection, checking, and maintenance of equipment (e.g., optical comparators, micrometers, dial calipers), and lack of calibration documentation, as required by 21 CFR 820.72(a