FDA WARNING_LETTER - Caridian BCT Inc. - November 11, 2010

On October 19 - November 11, 2010, the FDA inspected Caridian BCT Inc. in Lakewood, Colorado, a manufacturer of Class II automated blood cell separators and associated disposable collection sets. The inspection revealed that the devices are adulterated under section 501(h) of the Act, as manufacturing, packing, storage, or installation methods do not conform to the Quality System (QS) regulation (21 CFR Part 820).

Significant deviations include: 1. Failure to establish and maintain complaint procedures (21 CFR 820.198(a) and (b)), leading to uninvestigated complaints, insufficient information for MDR determinations, and failure to identify MDR events. 2. Failure to validate processes where results cannot be fully verified by subsequent inspection and test (21 CFR 820.75(a)), specifically the preparation of bonding solutions for disposable set components. 3. Failure to document in-process and final acceptance activities (21 CFR 820.80(e)), including final leak tests, in-process occlusion tests, and verification of equipment setup. 4. Failure to establish and maintain corrective and preventive action procedures for analyzing complaints (21 CFR 820.100(a)), particularly for software defect complaints. 5. Failure to adequately control environmental conditions (21 CFR 820.