# FDA 483 - Indoco Remedies Limited - February 28, 2023

Source: https://www.globalkeysolutions.net/records/483/indoco-remedies-limited/a0b8f4bc-e72d-4a8e-8082-dd33846ba306

> FDA 483 for Indoco Remedies Limited on February 28, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Indoco Remedies Limited
- Inspection Date: 2023-02-28
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Indoco Remedies Limited, a drug manufacturer in Verna, Goa, India, was inspected by the FDA and received a Form 483 with four observations. The inspection revealed significant deficiencies in aseptic processing, including inadequate microbiological contamination prevention, environmental monitoring, and equipment maintenance. Additionally, laboratory controls for component testing were found to be lacking scientific soundness.

## Related Documents

- [483 - 2018-11-21](https://www.globalkeysolutions.net/records/483/indoco-remedies-limited/48ea3579-abfc-4129-a059-9846d21b77c4)
- [483 - 2016-09-04](https://www.globalkeysolutions.net/records/483/indoco-remedies-limited/2fd4d5dd-2a44-42cd-b4ea-dce2f3ee2c1c)
- [WARNING_LETTER - 2019-01-25](https://www.globalkeysolutions.net/records/warning_letter/indoco-remedies-limited/36064184-0cc5-480f-bb1b-f0630c35a051)
- [483 - 2019-06-04](https://www.globalkeysolutions.net/records/483/indoco-remedies-limited/622ca7ca-e805-4c66-92ba-61f7983ffd22)
- [483 - 2019-06-04](https://www.globalkeysolutions.net/records/483/indoco-remedies-limited/b3d571bc-569e-4cd2-9126-ad862cb1eccd)

## Related Officers

- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/jeffrey-p-raimondi/7576ca4e-d9e8-4015-9ae6-9498e76058d3)
- [Consumer Safety Officer ](https://www.globalkeysolutions.net/people/anastasia-m-shields/a22b8d52-e3f9-4e61-aa3f-6f03ff2f59df)

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

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