Teco Diagnostics – FDA Warning Letter, Apr 26, 2010

On August 20, 2010, the FDA issued a Warning Letter to Teco Diagnostics following an inspection from March 24 to April 26, 2010. The inspection revealed that Teco Diagnostics' UriTek TC-101 Urine Strip Reader, 10SGL Clinistrip Urine reagent strip, and other urine strip readers and strips are adulterated under 21 U.S.C. 351(h) because their manufacturing, packing, storage, or installation methods do not conform to the Quality System (QS) regulation (21 C.F.R. Part 820).

Key violations include: 1. Failure to establish and maintain adequate corrective and preventive action (CAPA) procedures, specifically regarding identifying actions to prevent recurrence and verifying/validating CAPA effectiveness (21 CFR 820.100(a)(3), (a)(4)). 2. Failure to adequately establish and maintain procedures for monitoring and controlling process parameters for validation processes (21 CFR 820.75(b)), exemplified by undocumented re-validation of dryers. 3. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a designated unit (21 CFR 820.198(a)), with instances of non-compliance with internal procedures and incomplete complaint records (21 CFR 820