# FDA 483 - St. Theresa's General Hospital - June 08, 2012

Source: https://www.globalkeysolutions.net/records/483/st-theresas-general-hospital/a84f3703-2efc-4165-9af2-4eb89fe1a28f

> FDA 483 for St. Theresa's General Hospital on June 08, 2012. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: St. Theresa's General Hospital
- Inspection Date: 2012-06-08
- Product Type: drugs
- Office Name: FDA District Office — Silver Springs, Maryland
- Summary: An FDA inspection of St. Theresa's General Hospital, a clinical facility in Hyderabad, India, identified significant deviations from study protocols during a bioequivalence study. Observations included failures to adhere to subject inclusion/exclusion criteria and improper blood sampling procedures. These findings indicate a lack of adherence to established research protocols.

## Related Officers

- [Mary E. Wilkerson-Brinsko](https://www.globalkeysolutions.net/people/mary-e-wilkerson-brinsko/2e37e0e8-ebcb-4861-92ef-9ba1299871bc)

Company: https://www.globalkeysolutions.net/companies/st-theresas-general-hospital/9d9ad426-6fee-4256-8e86-34152d18c35c

Office: https://www.globalkeysolutions.net/offices/fda-district-office-silver-springs-maryland/079bb75c-3759-4baa-baed-4159edd64552