Hyphen BioMed sasu – FDA Warning Letter, Jun 20, 2012

On September 5, 2013, the FDA issued a Warning Letter to Hyphen BioMed following an inspection from June 18-20, 2012, in Neuville Sur Oise, France. The inspection found that Hyphen BioMed, a manufacturer of Class II biological reagents for hemostasis and thrombosis (e.g., Heparin Assay), was not in conformity with the Quality System (QS) regulation (21 CFR Part 820), rendering their devices adulterated under section 501(h) of the Act.

The letter detailed seven violations, including: 1. **Failure to establish and maintain adequate CAPA procedures (21 CFR 820.100(a)(1))**: Procedures lacked requirements for analyzing quality data to identify causes of nonconforming products. The firm's response was inadequate, lacking retrospective review outcomes. 2. **Failure to establish and maintain adequate procedures for nonconforming product disposition (21 CFR 820.90(b)(1))**: Justification for "accept as such" disposition was not documented, and nonconformances were not recorded in the firm's defect log. The response was inadequate, lacking retrospective review outcomes. 3. **Failure to establish and maintain rework procedures (21 CFR 820.90(b)(2))**: No procedure existed for rework activities, and