# FDA 483 - JPR Labs Private Limited - September 16, 2022

Source: https://www.globalkeysolutions.net/records/483/jpr-labs-private-limited/a4927aa8-1d5b-4d2a-a66f-8c5ae23425bc

> FDA 483 for JPR Labs Private Limited on September 16, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: JPR Labs Private Limited
- Inspection Date: 2022-09-16
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of JPR Labs Private Limited, an API-Intermediate Manufacturer in Paravada, India, revealed significant deficiencies. These included the permanent loss of historic electronic laboratory data, inadequate review of deviation investigations, and poor maintenance of equipment leading to contamination risks. Additionally, written procedures for preventative maintenance were found to be deficient or not followed.

## Related Officers

- [Bryan L. Mcguckin](https://www.globalkeysolutions.net/people/bryan-l-mcguckin/33eaa16d-a642-4945-81f3-5d9ac180c2db)

Company: https://www.globalkeysolutions.net/companies/jpr-labs-private-limited/9e8051f5-1d65-454b-8c00-d91d13e73e1c

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1