FDA WARNING_LETTER - Inova Health Care Services, Inova Blood Donor Services - February 13, 2012

On May 3, 2012, the FDA issued a Warning Letter to Inova Health Care Services, Inova Blood Donor Services, following an inspection from January 23 to February 13, 2012. The inspection revealed numerous significant violations of Current Good Manufacturing Practice (CGMP) regulations for blood and blood products (21 CFR Parts 600-680), rendering their products adulterated under Section 501(a)(2)(B) of the FD&C Act.

Key violations include: 1. **Donor Eligibility:** A donor with blood pressure 184/77, exceeding normal limits per SOP IBS 03-101, was accepted, and the resulting blood product was distributed. (21 CFR § 640.3(b)(2)) 2. **Equipment Calibration/Maintenance:** Failure to perform regularly scheduled weekly and bi-weekly maintenance on multiple infectious disease testing equipment (e.g., for HIV, HCV, Chagas, HBV, HTLV 1/2, West Nile, ABO, syphilis) as required by manufacturer specifications and SOPs (e.g., IBS 07-605, IBS 07-728, IBS 07-726, IBS 07-121). (21 CFR § 606.60(a)) 3.