# Indoco Remedies Limited – FDA 483, Jun 4, 2019

Source: https://www.keypedia.com/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.

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## Related Officers

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

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