# FDA 483 - Shriram Institute for Industrial Research - February 29, 2024

Source: https://www.keypedia.com/records/483/shriram-institute-for-industrial-research/0d11146c-f589-4f38-a4a2-180de5414188

> FDA 483 for Shriram Institute for Industrial Research on February 29, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Shriram Institute for Industrial Research
- Inspection Date: 2024-02-29
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: The FDA inspected Shriram Institute for Industrial Research in Delhi, India, a control testing laboratory, and issued a Form 483. The inspection revealed significant deficiencies including inadequate quality control unit procedures, unreliable electronic records and laboratory instrument validation, unverified testing methods, insufficient investigation of discrepancies, and a lack of cGMP/GLP training for employees. These issues indicate a systemic failure to adhere to good manufacturing and laboratory practices.

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## Related Officers

- [Rellia M Hicks](https://www.keypedia.com/people/rellia-m-hicks/81dffbe9-ab85-4bae-8bb3-fdfd5b3cd97c)
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Company: https://www.keypedia.com/companies/shriram-institute-for-industrial-research/999ee337-4fdd-4e9d-83e8-fab862064f23

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1