# FDA 483 - Intas Pharmaceuticals Ltd. - December 07, 2023

Source: https://www.keypedia.com/records/483/intas-pharmaceuticals-ltd/83848914-69b1-4d19-b2fb-ad19cbd9e73f

> FDA 483 for Intas Pharmaceuticals Ltd. on December 07, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Intas Pharmaceuticals Ltd.
- Inspection Date: 2023-12-07
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Intas Pharmaceuticals Limited in Ahmedabad, India, received a Form 483 with seven observations during an inspection from November 30 to December 7, 2023. The inspection revealed significant deficiencies in quality control, including inadequate OOS investigations, poor laboratory controls, and failures in quality unit oversight. Additionally, issues with microbiological contamination prevention, equipment qualification, and laboratory record-keeping were noted, indicating a broad range of GMP non-compliance.

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## Related Officers

- [Aditi S. Thakur](https://www.keypedia.com/people/aditi-s-thakur/1c810eb2-86b0-4cae-b51d-43f3fb276ade)
- [ Investigator, Consumer Safety Officer](https://www.keypedia.com/people/thuy-t-nguyen/1cfb5467-f0b7-49b8-85c1-00373692e35e)
- [Aditi Thakur, Sr Pharm Quality Assessor](https://www.keypedia.com/people/aditi-thakur-sr-pharm-quality-assessor/2ad81368-a4c7-4e20-b1b5-c5fc85ff154c)
- [other](https://www.keypedia.com/people/jeanne-m-fringer/4d970694-416e-42d6-9ec3-7bf3e337fb9a)
- [Thuy Thanh Nguyen, DHSc, Branch Chief](https://www.keypedia.com/people/thuy-thanh-nguyen-dhsc-branch-chief/597b8ce7-1f51-4ede-b114-14df8bff3e01)

Company: https://www.keypedia.com/companies/intas-pharmaceuticals-ltd/b19b63c2-446c-413c-9c30-1617f981d92a

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd