FDA WARNING_LETTER - Beckman Coulter, Inc. - June 02, 2011

On November 1, 2011, the FDA issued a Warning Letter to Beckman Coulter, Inc. following an inspection from February 28, 2011, to June 2, 2011, at their Miami, FL facility, which manufactures Class I and II in vitro diagnostic products. The inspection revealed that the devices are adulterated under 21 U.S.C. § 351(h) due to non-conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System regulation (21 CFR Part 820).

Key violations include: 1. **Failure to establish and maintain adequate procedures for implementing corrective and preventive action (CAPA)** (21 CFR 820.100(a)). Specific issues included inadequate failure investigations, failure to extend CAPA investigations to assess OEM quality systems, conflicting information in failure investigations, and failure to implement established procedures for supplier corrective actions. The adequacy of the firm's responses regarding CAPA procedures could not be determined without evidence of implementation. 2. **Failure to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints** (21 CFR 820.198(a)). Not all customer feedback investigations included required information, and many lacked documented investigation results or proper determination of the need for CAPA. Complaint investigation results also contained inaccurate information regarding recurrence and association with open investigations.