# FDA WARNING_LETTER - St Mary's Hospital and Medical Center, Inc. - June 15, 2012

Source: https://www.globalkeysolutions.net/records/warning_letter/st-marys-hospital-and-medical-center-inc/71aebfc2-9f5b-4a04-aabf-17024120f79d

> FDA WARNING_LETTER for St Mary's Hospital and Medical Center, Inc. on June 15, 2012. Product: Other. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: St Mary's Hospital and Medical Center, Inc.
- Inspection Date: 2012-06-15
- Product Type: Other
- Office Name: Department of Health and Human Services
- Summary: The FDA conducted an inspection of St. Mary's Hospital and Medical Center from June 4 to June 15, 2012, identifying deviations from 21 U.S.C. 351 and 21 CFR Parts 606, 640, and 211.

Violations include:
1. **Failure to maintain Red Blood Cell (RBC) temperature:** RBCs were not consistently stored between 1 and 6°C. The "Packing and Returning of Units Transported on (b)(4) log" showed instances where RBC units, returned as out of range, were subsequently transfused or shipped to other establishments.
2. **Inadequate record-keeping:** The firm failed to concurrently maintain records for storage and distribution of blood units, hindering traceability. Examples include incomplete storage documentation on the (b)(4) log and a unit transfused without storage documentation.
3. **Improper equipment calibration:** Thermometers were not calibrated as per SOPs. On March 6, 2012, three thermometers failed calibration (off by 3-5 degrees) but remained in use.
4. **Insufficient quality control review:** The quality control unit failed to review procedures impacting drug product quality. Numerous (b)(4) logs, despite deviations in shipping/storage temperatures and traceability, lacked a (b)(4) quality review.

The FDA acknowledged the firm's

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- [District Director](https://www.globalkeysolutions.net/people/latonya-mitchell/433fa355-5a9b-4723-876c-782d1ca5737d)

Company: https://www.globalkeysolutions.net/companies/st-marys-hospital-and-medical-center-inc/5b12f1b0-f390-401d-99e6-7e7fd52b8aa1

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