# Shree Hospital – FDA 483, Oct 21, 2023

Source: https://www.keypedia.com/records/483/shree-hospital/1f902c58-f216-4ac1-9839-4affca420438

> FDA 483 for Shree Hospital on October 21, 2023. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Shree Hospital
- Inspection Date: 2023-10-21
- Product Type: drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: Shree Hospital, a biopharmaceutics clinical facility in Pune, India, was cited for significant deficiencies during a bioequivalence/bioavailability clinical study inspection. The inspection revealed failures to adhere to Good Clinical Practices, including issues with informed consent, multiple protocol deviations, inadequate record-keeping, and uncalibrated equipment used for processing pharmacokinetic samples. These findings indicate a serious lack of control over critical aspects of clinical trial conduct.

## Related Officers

- [investigator](https://www.keypedia.com/people/courtney-n-long/32118415-bc77-4ac2-8f90-947e43cf10ff)

Company: https://www.keypedia.com/companies/shree-hospital/68379e10-45dc-4328-8ce9-6a54f17205e1

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c