# FDA 483 - Panexcell Clinical Lab PVT. LTD. - January 19, 2018

Source: https://www.keypedia.com/records/483/panexcell-clinical-lab-pvt-ltd/0f951501-0b06-4b7b-8baf-daee59827ce7

> FDA 483 for Panexcell Clinical Lab PVT. LTD. on January 19, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Panexcell Clinical Lab PVT. LTD.
- Inspection Date: 2018-01-19
- Product Type: drugs
- Office Name: Center for Veterinary Medicine
- Summary: Panexcell Clinical Lab (P) LTD., a Clinical Research Organization in Navi Mumbai, India, was inspected by the FDA. The inspection revealed that an adequate final report was not provided to the sponsor shortly after the completion of an investigator's participation in a study. Specifically, incorrect adverse event onset dates were reported in a clinical study report for an ANDA study.

## Related Officers

- [investigator](https://www.keypedia.com/people/susanne-m-richardson/a3faf1fc-777e-4c8a-a053-8bd53a12db00)

Company: https://www.keypedia.com/companies/panexcell-clinical-lab-pvt-ltd/6e860888-0a3e-4564-ae78-8152bd939d4e

Office: https://www.keypedia.com/offices/center-for-veterinary-medicine/7e30a309-56e4-4e7a-8b8b-e07674bb07b4