FDA WARNING_LETTER - Care Diagnostica GmbH - December 13, 2012

On April 23, 2013, the FDA issued a Warning Letter to Care Diagnostica GmbH following an inspection from December 10-13, 2012, in Moellersdorf, Austria. The inspection found that the firm's IVD Test Kits are adulterated under 21 U.S.C. § 351(h) because manufacturing methods, facilities, or controls do not conform to the Quality System regulation (21 CFR Part 820). The firm's January 25, 2013, response to the FDA 483 was not reviewed due to late submission.

Violations include: 1. Failure to establish and maintain adequate Corrective and Preventive Action (CAPA) procedures (21 CFR 820.100(a)). The firm admitted to not having a CAPA procedure. 2. Failure to ensure manufacturing equipment meets specified requirements and is appropriately designed, constructed, placed, and installed (21 CFR 820.70(g)). The firm lacked validation records for new manufacturing equipment, a repeat observation from a previous inspection. 3. Failure to maintain records of changes to documents (21 CFR 820.40(b)). The firm stated they do not keep document changes. 4. Failure to establish and maintain procedures for adequate sampling methods and to review sampling plans