# FDA 483 - Indoco Remedies Limited - July 26, 2024

Source: https://www.keypedia.com/records/483/indoco-remedies-limited/356b669e-1931-4335-90e7-4a58711730a8

> FDA 483 for Indoco Remedies Limited on July 26, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Indoco Remedies Limited
- Inspection Date: 2024-07-26
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Indoco Remedies Limited in Vasco Da Gama, Goa, India, revealed significant deficiencies in both sterile and non-sterile drug manufacturing. Key issues included inadequate complaint investigations, failures in aseptic process validation, and a lack of adherence to quality control unit responsibilities. The firm also exhibited poor facility maintenance, insufficient environmental monitoring, and deficiencies in in-process material testing, indicating a broad range of cGMP violations.

## Related Documents

- [WARNING_LETTER - 2024-07-26](https://www.keypedia.com/records/warning_letter/indoco-remedies-limited/e38cf119-2868-489e-987f-8acda3d4a076) — date: July 26, 2024
- [483 - 2024-07-26](https://www.keypedia.com/records/483/indoco-remedies-limited/22f99fe9-3f03-46d5-8e6b-9e2fbe2970aa) — date: July 26, 2024
- [483 - 2024-07-16](https://www.keypedia.com/records/483/indoco-remedies-limited/2c97c02d-1919-4a3c-99fb-29c1b30ddde5) — date: July 16, 2024
- [483 - 2023-02-28](https://www.keypedia.com/records/483/indoco-remedies-limited/a0b8f4bc-e72d-4a8e-8082-dd33846ba306) — date: February 28, 2023
- [483 - 2019-06-04](https://www.keypedia.com/records/483/indoco-remedies-limited/b3d571bc-569e-4cd2-9126-ad862cb1eccd) — date: June 4, 2019

## Related Officers

- [Wayne D. Mcgrath](https://www.keypedia.com/people/wayne-d-mcgrath/42db5ab0-2e0b-4909-951c-e7621cd04f6e)
- [Saleem A. Akhtar](https://www.keypedia.com/people/saleem-a-akhtar/1ea49212-bea5-4d43-bd0a-cdede4d3b1cf)

Company: https://www.keypedia.com/companies/indoco-remedies-limited/00606519-7338-4109-b20b-b6858eae2f03

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