# Lambda Therapeutic Research Ltd. – FDA 483, Jan 20, 2020

Source: https://www.keypedia.com/records/483/lambda-therapeutic-research-ltd/fc019d06-f560-458a-bfc2-c5291b7ab3b6

> FDA 483 for Lambda Therapeutic Research Ltd. on January 20, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lambda Therapeutic Research Ltd.
- Inspection Date: 2020-01-20
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: During an inspection, Lambda Therapeutic Research, Ltd., a Contract Research Organization in Ahmedabad, India, was cited for failing to report complete precision data for anti-drug and neutralizing antibody assays. This single observation indicates a concern regarding data integrity and reporting practices in method validation. The firm did not include all generated precision data from specific runs for two key assays associated with clinical studies.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/amanda-e-lewin/7f30b6cb-52f1-4fc2-a8e5-90f037a4d73e)
- [other](https://www.keypedia.com/people/makini-cobourne-duval/8eec148c-3eb2-4673-87ea-efc4e64821bb)

Company: https://www.keypedia.com/companies/lambda-therapeutic-research-ltd/e4515c16-4ff4-451a-9d2f-b4b1668eb47c

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4