NovaLung Gmbh – FDA Warning Letter, Nov 17, 2011

On April 2, 2012, the FDA issued a Warning Letter to NovaLung GmbH following a November 14-17, 2011, inspection in Oberstenfeld, Germany, which found their Novalung Surgical Lung Assist (sLA) device adulterated under 21 U.S.C. § 351(h). The firm's manufacturing, packing, storage, or installation methods did not conform to the Quality System regulation (21 CFR Part 820).

The FDA deemed NovaLung's November 23, 2011, response to the Form FDA 483 inadequate. Key violations included: 1. **Failure to establish and maintain adequate CAPA procedures (21 CFR 820.100(a)(4))**: At least seven of eleven reviewed CAPAs lacked documentation of effectiveness checks. The firm failed to verify/validate CAPA effectiveness and impact on finished devices. 2. **Failure to establish and maintain adequate complaint handling procedures (21 CFR 820.198(a))**: Non-conformances and customer feedback reports were not processed as complaints, nor included in complaint files for review, evaluation, or investigation. 3. **Failure to establish and maintain an adequate Design History File (DHF) (21 CFR 820.30(j))**: The redesigned D