# FDA 483 - P.D.E.A.'s Ayurved Rugnalaya & Sterling Multispeciality Hospital - February 16, 2023

Source: https://www.globalkeysolutions.net/records/483/pdeas-ayurved-rugnalaya-sterling-multispeciality-hospital/18a30e5c-b52a-46e8-86cb-3a892410bb78

> FDA 483 for P.D.E.A.'s Ayurved Rugnalaya & Sterling Multispeciality Hospital on February 16, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: P.D.E.A.'s Ayurved Rugnalaya & Sterling Multispeciality Hospital
- Inspection Date: 2023-02-16
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of P.D.E.A.'s Ayurved Rugnalay & Sterling Multispeciality Hospital in Pune, India, revealed significant failures in conducting foreign clinical studies according to good clinical practices. The facility did not maintain adequate and accurate case histories and records for a bioavailability/bioequivalence study, exhibiting numerous data integrity issues and missing documentation. Additionally, an untoward medical occurrence was not reported as an adverse event, indicating serious deficiencies in clinical trial oversight.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/pdeas-ayurved-rugnalaya-sterling-multispeciality-hospital/ec98e452-1aff-458b-ad0c-e0bff5ab33ad

Office: https://www.globalkeysolutions.net/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8