# FDA WARNING_LETTER - Regional Medical Center - February 02, 2011

Source: https://www.keypedia.com/records/warning_letter/regional-medical-center/706c3f23-dd64-4e24-ad6e-953da2bd1196

> FDA WARNING_LETTER for Regional Medical Center on February 02, 2011. Product: Biologics. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Regional Medical Center
- Inspection Date: 2011-02-02
- Product Type: Biologics
- Office Name: Cincinnati District Office
- Summary: 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

## Related Officers

- [Teresa C. Thompson](https://www.keypedia.com/people/teresa-c-thompson/b41b98e5-2a7c-4f19-923b-058a197a8fd4)

Company: https://www.keypedia.com/companies/regional-medical-center/da9198d0-c255-4ca4-a87d-2f35231dbe0a

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22