Tecval Medical Sarl – FDA Warning Letter, Nov 7, 2012

On January 25, 2013, the FDA issued a Warning Letter to Tecval Medical Sàrl in Yverdon-Les-Bains, Switzerland, following an inspection from November 5-7, 2012. The inspection revealed that the firm's Flutter Aptalis device is adulterated under section 501(h) of the Act, as its manufacturing, packing, storage, or installation methods do not conform to the Quality System regulation (21 CFR Part 820).

The letter details eight significant violations: 1. **Failure to establish and maintain design change procedures (21 CFR 820.30(i))**: No written procedures for design changes, and the documentation form lacks design validation/verification. The firm's response was inadequate as it didn't address when validation/verification is required. 2. **Failure to establish and maintain purchasing control procedures (21 CFR 820.50)**: No procedures for evaluating and selecting suppliers, contractors, and consultants, despite being responsible for material sourcing. The adequacy of the response is undetermined, pending translated procedures by end of February 2013. 3. **Failure to establish and maintain acceptance activity procedures (21 CFR 820.80(a))**: No procedures for receiving, in-process, or final acceptance activities. Adequacy of response is undetermined,