Fenwal, a Fresenius-Kaby Company – FDA Warning Letter, Apr 25, 2013

This FDA Warning Letter, dated [Date of Letter], was issued to Fenwal, a Fresenius-Kabi Company, following an inspection of their pharmaceutical and medical device manufacturing facility in Maricao, Puerto Rico, from April 9 to April 25, 2013. The inspection identified significant violations of Current Good Manufacturing Practice (CGMP) regulations for Finished Pharmaceuticals (21 CFR Parts 210 and 211), rendering their drug products adulterated. Additionally, the firm failed to submit NDA Field Alert Reports (FARs) as required by 21 CFR § 314.81(b)(1)(i) and (ii) and section 505(k) of the Act.

Key violations include: 1. **Failure to thoroughly investigate discrepancies (21 CFR § 211.192):** The firm received multiple consumer complaints regarding mislabeled bags, inadequate bag size, defective components, and product mix-ups in blood collection and component preparation units. Investigations failed to identify root causes or extend to other potentially affected batches/products. This is a repeat deficiency from 2010 and 2012 inspections. 2. **Failure to establish and follow procedures for labels/packaging (21 CFR § 211.130(a)):** Since 2010, the firm received multiple complaints about missing or incorrect labels.