FDA WARNING_LETTER - Dexta Corporation - March 06, 2014

An FDA inspection of Dexta Corporation (March 4-6, 2014) found its medical chairs, surgical lights, and dental operative units adulterated under section 501(h) of the Act, non-conforming with the Quality System (QS) regulation (21 CFR Part 820). Additionally, devices are misbranded per section 502(o) and 510(j) for improper listing.

Key QS violations include failures in process validation (21 CFR 820.75(a)), process control (21 CFR 820.70(a)), purchasing controls (21 CFR 820.50), acceptance activities (21 CFR 820.80(a)), corrective and preventive actions (21 CFR 820.100), complaint handling (21 CFR 820.198(a)), training (21 CFR 820.25(b)), management reviews (21 CFR 820.20(c)), quality audits (21 CFR 820.22), environmental control (21 CFR 820.70(c)), non-conforming product control (21 CFR 820.90(a)), document control (21 CFR 820.40), and equipment calibration (21 CFR 820.72(a)).

The firm's response to the FDA 483 was inadequate, lacking documented corrections. Dexta must implement prompt, comprehensive corrective actions addressing systemic issues, providing written notification and documentation within fifteen business days. Non-compliance risks regulatory actions like seizure, injunction, civil money penalties, and impacts on federal contracts, premarket approvals, and Certificates to Foreign Governments. The letter emphasizes the firm's responsibility to investigate and correct all underlying problems.