FDA WARNING_LETTER - Tetracore, Inc. - May 28, 2009

The FDA inspected Tetracore, Inc. in Rockville, MD, from May 21-28, 2009, identifying violations related to their Redline Alert Anthrax Test kit, classified as a medical device. The inspection revealed the devices were adulterated under section 501(h) of the Act due to non-conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820). Specific QS deficiencies included failure to adequately validate processes, such as lyophilization, as required by 21 CFR 820.75(a); failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints (21 CFR 820.198(a)); and failure to establish and maintain adequate design control procedures (21 CFR 820.30), specifically lacking mechanisms for addressing incomplete requirements and ensuring independent design reviews. Additionally, the devices were found misbranded under section 502(t)(2) for failing to furnish required information under section 519 and 21 CFR Part 803, specifically the failure to develop, maintain, and implement written Medical Device Reporting (MDR) procedures (21 CFR 803.17). The firm's response to the FDA 483 was deemed inadequate for all noted violations. Tetracore must promptly correct these violations and provide a written response within fifteen working days, detailing corrective actions, prevention plans, and a timetable. Failure to comply may result in severe regulatory actions, including seizure, injunction, civil money penalties, and impact on federal contracts and product approvals.