# FDA 483 - Synchron Research Services Pvt. Ltd. - November 22, 2019

Source: https://www.globalkeysolutions.net/records/483/synchron-research-services-pvt-ltd/956fec16-6a59-471c-a5b3-27c8416e9c34

> FDA 483 for Synchron Research Services Pvt. Ltd. on November 22, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Synchron Research Services Pvt. Ltd.
- Inspection Date: 2019-11-22
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: An FDA inspection of Synchron Research Services Pvt. Ltd., a Contract Research Organization in Ahmedabad, India, revealed significant issues with incomplete and inaccurate study documentation. Specifically, discrepancies were found in the recording of sample receipt and storage details, including dates, locations, temperatures, and times. These findings indicate a moderate severity of non-compliance related to data integrity and record-keeping practices.

## Related Officers

- [other](https://www.globalkeysolutions.net/people/makini-cobourne-duval/8eec148c-3eb2-4673-87ea-efc4e64821bb)
- [issuing_officer](https://www.globalkeysolutions.net/people/kara-a-scheibner/63643a3f-4a8e-4dcc-8f1a-6fcf98519aad)

Company: https://www.globalkeysolutions.net/companies/synchron-research-services-pvt-ltd/a575855c-a53e-40d0-bc75-be0613582091

Office: https://www.globalkeysolutions.net/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321