# FDA 483 - Shriram Institute for Industrial Research - October 22, 2019

Source: https://www.globalkeysolutions.net/records/483/shriram-institute-for-industrial-research/a20e477d-3886-4f26-bac9-ddf583323abe

> FDA 483 for Shriram Institute for Industrial Research on October 22, 2019. 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: 2019-10-22
- 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 found significant deficiencies. The firm failed to follow or establish written procedures for quality control, method verification, and electronic data management. These issues compromised data integrity, laboratory record-keeping, and the overall reliability of drug product testing.

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## Related Officers

- [June P. Page](https://www.globalkeysolutions.net/people/june-p-page/3b1ffc71-ce2e-47f5-aefe-87fd5eebc792)
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Company: https://www.globalkeysolutions.net/companies/shriram-institute-for-industrial-research/999ee337-4fdd-4e9d-83e8-fab862064f23

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