FDA WARNING_LETTER - BCIW Inc. - January 21, 2010

The FDA inspected BCIW, Incorporated, located in Los Angeles, CA, from January 19-21, 2010, regarding its manufacture of BioSensor-T (micro-thermocouples), a finished medical device. The inspection revealed that the devices are misbranded under section 502(t)(2) of the Federal Food, Drug, and Cosmetic Act, due to the firm's failure to furnish required information under section 519 and 21 CFR Part 803, the Medical Device Reporting (MDR) regulation. A significant deviation identified was the failure to develop, maintain, and implement written MDR procedures, as required by 21 CFR 803.17. Furthermore, the FDA noted non-conformances with section 501(h) of the Act, pertaining to current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR 820). Specifically, the firm failed to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as mandated by 21 CFR 820.198(a). BCIW is required to take prompt corrective action and notify the FDA within fifteen working days with a detailed plan, including documentation and a timetable. Failure to correct these violations could result in regulatory actions such as seizure, injunction, civil money penalties, and impact federal contracts, premarket approvals for Class III devices, and Certificates to Foreign Governments. The FDA emphasized that these violations may indicate broader issues within the firm's manufacturing and quality assurance systems.