# Notrox Research Private Limited – FDA 483

Source: https://www.keypedia.com/records/483/notrox-research-private-limited/c57cecfd-20ef-48c1-95d6-1649cb008bb4

> FDA 483 for Notrox Research Private Limited on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Notrox Research Private Limited
- Product Type: drugs
- Office Name: Division of Blood Components and Devices
- Summary: Notrox Research Private Limited, a Contract Research Organization in Bangalore, India, received a Form 483 with two observations. The inspection revealed deficiencies in method validation calculations for inter-batch precision and accuracy, as well as inadequate documentation of pharmacokinetic sample handling procedures during a clinical study. These issues indicate concerns with data integrity and adherence to proper study conduct.

## Related Officers

- [Business Analyst/Provider Enrollment Specialist](https://www.keypedia.com/people/lakecha-n-lewis/39b6305d-2a9f-448b-9a14-e412b43c8522)
- [investigator](https://www.keypedia.com/people/sripal-r-mada/38ce7c12-1405-436b-ac3e-55149c953537)

Company: https://www.keypedia.com/companies/notrox-research-private-limited/7cbb5fa2-40ef-4bc4-8ae7-7870b502102c

Office: https://www.keypedia.com/offices/division-of-blood-components-and-devices/02cc5ccf-d21e-445f-91e7-474736bc8917