FDA WARNING_LETTER - Pega Medical Inc. - March 31, 2010

An FDA inspection of Pega Medical Inc. in Laval, Quebec, Canada, from March 29-31, 2010, revealed that the firm's Fassier-Duval IM Telescopic System and Hinge Pediatric Plating System devices are misbranded under section 502(t)(2) of the Act, due to a failure to furnish required Medical Device Reporting (MDR) information (21 U.S.C. 360i, 21 C.F.R. Part 803). Specifically, the firm failed to adequately develop, maintain, and implement written MDR procedures as required by 21 CFR 803.17. Additionally, the inspection identified eight significant deficiencies related to Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 C.F.R. Part 820). These include failures in establishing and maintaining procedures for supplier requirements (21 CFR 820.50(a)), design validation (21 CFR 820.30(g)), design change controls (21 CFR 820.30(i)), process validation documentation (21 CFR 820.75(a)), purchased product conformity (21 CFR 820.50), complaint handling (21 CFR 820.198(a)), nonconforming product disposition (21 CFR 820.90(b)), and document control (21 CFR 820.40). The firm's responses to the FDA 483 observations were deemed inadequate, lacking evidence of implementation and systemic corrective actions. Pega Medical Inc. must promptly correct these violations and notify the FDA within fifteen working days with a detailed plan and documentation. Failure to comply may lead to regulatory actions, including device detention, denial of premarket approvals, and refusal of Certificates to Foreign Governments. A follow-up inspection will be required.