Cenova Innovation and Productions AB – FDA Warning Letter, Sep 15, 2010

On February 25, 2011, the FDA issued a Warning Letter to Cenova Innovation and Productions AB, a contract manufacturer and packager of Class II and III medical devices, including the "CoreTherm" System. This letter followed an inspection conducted from September 13-15, 2010, in Mjolby, Sweden. The inspection revealed that the devices were adulterated under 21 U.S.C. § 351(h) due to non-conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820).

Key violations included: 1. Failure to establish and maintain adequate procedures for corrective and preventive action (21 CFR 820.100(a)), specifically lacking provisions for statistical analysis of quality data and verification/validation of corrective actions. 2. Failure to establish and maintain procedures to control nonconforming product (21 CFR 820.90(a)), with inadequate investigation of nonconformances and notification of responsible parties. 3. Failure to establish and maintain rework procedures (21 CFR 820.90(b)(2)), evidenced by an unproceduralized rework of a mislabeled batch. 4. Failure to establish and maintain adequate complaint handling procedures (21 CFR 820.198