# FDA 483 - Intas Pharmaceuticals Limited - December 14, 2018

Source: https://www.keypedia.com/records/483/intas-pharmaceuticals-limited/d7d4f9f0-3246-4bd4-b45d-b1149c0a717e

> FDA 483 for Intas Pharmaceuticals Limited on December 14, 2018. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Intas Pharmaceuticals Limited
- Inspection Date: 2018-12-14
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Intas Pharmaceuticals Limited in Ahmedabad, India, was inspected by the FDA from December 10-14, 2018. The inspection revealed a significant issue regarding the failure to follow procedures designed to prevent microbiological contamination during the manufacturing of sterile drug products. Specifically, an operator was not monitored in the aseptic filling room as required by the firm's own SOPs, and logbooks lacked documentation of critical activities or personnel monitoring.

## Related Documents

- [483 - 2022-12-02](https://www.keypedia.com/records/483/intas-pharmaceuticals-limited/aaef987c-6382-4641-8d0e-9fc48ace87ba)
- [WARNING_LETTER - 2025-09-17](https://www.keypedia.com/records/warning_letter/intas-pharmaceuticals-limited/5823afb5-cd04-4920-9a5a-ce851b44651c)
- [483 - 2018-06-08](https://www.keypedia.com/records/483/intas-pharmaceuticals-limited/6c433282-acc9-4639-89b9-e51ca154262e)
- [483 - 2019-08-02](https://www.keypedia.com/records/483/intas-pharmaceuticals-limited/d8b8b922-c242-4064-89d5-38ff992edec5)
- [483 - 2023-05-12](https://www.keypedia.com/records/483/intas-pharmaceuticals-limited/439bcecd-27da-49d0-b32b-ce7d8d990792)

## Related Officers

- [Vilmary Negrón Rodríguez](https://www.keypedia.com/people/vilmary-negron-rodriguez/2a7c90ba-9dc3-473f-9b79-06bcd312e06d)

Company: https://www.keypedia.com/companies/intas-pharmaceuticals-limited/0db00702-d7f6-4a8b-87d1-1b32ac236cc8

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