FDA WARNING_LETTER - Intec Industries Inc - August 10, 2010

An FDA inspection of Intec Industries, Inc. on August 3, 4, and 10, 2010, revealed that the firm's manufactured medical devices (face shields and extended eye shields with masks) are adulterated under Section 501(h) of the Federal Food, Drug, and Cosmetic Act. This is due to non-conformity with 21 CFR Part 820, the Quality System (QS) regulations. The inspection identified 11 serious deviations, including the failure to develop Medical Device Reporting procedures (21 CFR 803.17), establish written procedures for Corrective and Preventive Action (21 CFR 820.100(a)), and implement a complaint handling system (21 CFR 820.198(a)). Other critical deficiencies involved the lack of written procedures for purchasing controls (21 CFR 820.50), management review (21 CFR 820.20(c)), quality audits (21 CFR 820.22), and training (21 CFR 820.25(b)). The firm also failed to establish procedures for controlling non-conforming products (21 CFR 820.90(a)), maintain complete device master records (21 CFR 820.181), establish device history record procedures (21 CFR 820.184), and document in-process inspections (21 CFR 820.80(c)). Intec Industries' August 18, 2010, response to the Form FDA 483 was deemed inadequate as it lacked documentation of corrections. The FDA requires the firm to investigate the causes of these violations, prevent recurrence, and provide a written response within fifteen working days detailing specific corrective actions, supporting documentation, and a timeframe for completion. Failure to comply may result in legal action, including seizure and injunction, and could impact future contract awards.