# FDA 483 - Intas Pharmaceuticals Limited - May 28, 2019

Source: https://www.keypedia.com/records/483/intas-pharmaceuticals-limited/ce617d78-cad5-4a6b-9b44-9d98421912d8

> FDA 483 for Intas Pharmaceuticals Limited on May 28, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Intas Pharmaceuticals Limited
- Inspection Date: 2019-05-28
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Intas Pharmaceuticals Limited in Ahmedabad, India, revealed multiple deficiencies across its manufacturing and quality control operations. The firm failed to adequately handle complaints, follow quality control procedures for out-of-trend results and batch record reconciliation, and establish proper in-process controls and hold time studies. Additionally, master production records lacked specific operating parameters, investigations into discrepancies were insufficient, and equipment cleaning procedures were incomplete.

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Company: https://www.keypedia.com/companies/intas-pharmaceuticals-limited/cfedbb2f-5587-42dc-985b-044083dd01e5

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