# FDA 483 - Indoco Remedies Limited - June 04, 2019

Source: https://www.globalkeysolutions.net/records/483/indoco-remedies-limited/622ca7ca-e805-4c66-92ba-61f7983ffd22

> FDA 483 for Indoco Remedies Limited on June 04, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Indoco Remedies Limited
- Inspection Date: 2019-06-04
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Indoco Remedies Limited in Vasco Da Gama, Goa, received a Form 483 with four observations primarily concerning deficiencies in stability testing and quality control procedures for drug products. Issues included out-of-specification results for expired batches, inadequate investigation scope, and a lack of robust written programs for stability assessment and in-process material examination. These findings indicate significant concerns regarding product quality assurance and compliance with manufacturing standards.

## 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 - 2023-02-28](https://www.globalkeysolutions.net/records/483/indoco-remedies-limited/a0b8f4bc-e72d-4a8e-8082-dd33846ba306)
- [483 - 2019-06-04](https://www.globalkeysolutions.net/records/483/indoco-remedies-limited/b3d571bc-569e-4cd2-9126-ad862cb1eccd)

## Related Officers

- [Jose A. Cruz Gonzalez](https://www.globalkeysolutions.net/people/jose-a-cruz-gonzalez/a005cff1-0a90-4396-82c4-de4b0a579374)

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