FDA WARNING_LETTER - Regional Medical Center - February 02, 2011

The FDA conducted an inspection of Regional Medical Center from January 11 to February 2, 2011, documenting deviations from cGMP regulations for blood and blood components (21 CFR Parts 606-680) and Finished Pharmaceuticals (21 CFR Part 211). These deviations render blood products adulterated under Section 501(a)(2)(B) of the Federal Food, Drug and Cosmetic Act.

Violations include: 1. **Failure to determine donor suitability (21 CFR 640.3(a)(1)):** Approximately one-third of 100 donor cards were incomplete, with unanswered questions, incorrect "yes/no" responses, or adverse/discrepant answers. All donors were allowed to donate, resulting in 14 distributed and transfused blood products and 6 distributed for further manufacture. 2. **Failure to check computer system accuracy (21 CFR 211.68(b)):** Validation of the Hemocare Lifeline (HCLL) Donor Module 15 (Product Labeling) was incomplete. A system change from using social security numbers with dashes to without dashes created a risk of duplicate donor records, which the firm was aware of but did not implement a workaround. 3. **Failure to review records and investigate discrepancies (21 CFR 606.100(c)):** Thirteen weekly temperature