Millar Instruments, Inc. – FDA Warning Letter, Feb 2, 2012

On May 7, 2012, the FDA issued a Warning Letter to Millar Instruments, Inc. following an inspection from January 24 to February 2, 2012. The inspection revealed that the firm's reusable and disposable pressure transducer catheters, including urological, cardiovascular, and intracranial models, are adulterated under 21 U.S.C. § 351(h) because their manufacturing, packing, storage, or installation methods do not conform to the Quality System regulation (21 CFR Part 820).

Key violations include: 1. **Failure to validate processes (21 CFR 820.75(a)):** Processes for preparing catheter surfaces for adherence were not validated with a high degree of assurance, lacking protocols, acceptance criteria, worst-case testing, and verification of intended use. The firm's response was deemed inadequate as it did not provide referenced documents or sufficient supporting documentation for proposed corrective actions. 2. **Failure to establish and maintain procedures for finished device acceptance (21 CFR 820.80(d)):** The firm used non-validated in-house test methods for critical in-process and final device testing. Validation of test equipment and methods was inadequate, lacking protocols, acceptance criteria, and worst-case testing. The firm's response was inadequate, failing to provide supporting documentation for test method validity or proposed corrective actions. 3