Haemonetics Corporation – FDA Warning Letter, Jul 3, 2008

On June 26, 27, 30 and July 1, 3, 2008, the FDA inspected Haemonetics Corporation in Niles, Illinois, which manufactures thromboelastograph devices and accessories. The inspection revealed these devices are adulterated under section 501(h) of the Act, as manufacturing methods, facilities, or controls do not conform to the Quality System (QS) regulation (21 CFR Part 820).

Violations include: 1. **Failure to establish and maintain CAPA procedures (21 CFR 820.100(a)(4))**: * Supplier Corrective Action (SCA) SC# 0027 for Level II QC control issues lacked verification/validation of effectiveness, leading to continued nonconformances. The firm's response was inadequate, as implementation evidence was not provided, and the new SCA (SC# 0032) lacked a validation protocol/schedule. * SCA SC# 0028 for loose caps/low water levels lacked verification/validation of effectiveness. The firm's response was inadequate, as it did not demonstrate how effectiveness would be verified. Additionally, cap torque specifications were not documented in the device master record or work instructions (21 CFR 820.181(a)&(b)). 2. **Failure to identify actions needed to correct