# FDA 483 - ClinSync Clinical Research Pvt Ltd - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/clinsync-clinical-research-pvt-ltd/ad9ab895-1321-4f6d-b2b6-727417491e01

> FDA 483 for ClinSync Clinical Research Pvt Ltd on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ClinSync Clinical Research Pvt Ltd
- Product Type: drugs
- Office Name: FDA District Office — Silver Spring, Maryland
- Summary: An FDA inspection of ClinSync Clinical Research Pvt. Ltd. in Hyderabad, India, on January 10-13, 2020, revealed a significant issue regarding the retention of reserve samples. The firm failed to retain representative reserve samples of investigational product from multiple shipments used in studies submitted to the FDA. Additionally, there were discrepancies in the documentation of product shipments in clinical study reports.

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## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/clinsync-clinical-research-pvt-ltd/9443aac7-d0a8-4a05-87f4-e085f3d21415

Office: https://www.globalkeysolutions.net/offices/fda-district-office-silver-spring-maryland/c45b8acb-c066-4a6f-a2c3-e977108194c7