# FDA 483 - Indoco Remedies Limited (Plant I) - January 20, 2023

Source: https://www.globalkeysolutions.net/records/483/indoco-remedies-limited-plant-i/98381d61-704e-465e-8453-c84dc8652416

> FDA 483 for Indoco Remedies Limited (Plant I) on January 20, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Indoco Remedies Limited (Plant I)
- Inspection Date: 2023-01-20
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Indoco Remedies Limited (Plant I) in Vasco Da Gama, Goa, India, was cited for significant deficiencies during an FDA inspection from January 16-20, 2023. The observations highlight systemic failures in quality control, including inadequate investigations into equipment breakdowns, compromised data integrity, and insufficient oversight of manufacturing processes and laboratory controls. These issues collectively indicate a lack of assurance regarding the safety, effectiveness, and quality of the drug products manufactured.

## Related Documents

- [483 - 2018-01-19](https://www.globalkeysolutions.net/records/483/indoco-remedies-limited-plant-i/e01a0020-afb5-43b8-b1f0-6186bcc2c7dc)
- [483 - 2019-01-25](https://www.globalkeysolutions.net/records/483/indoco-remedies-limited-plant-i/e2568f3f-606a-4a92-be51-5e4b7b0664a6)
- [483 - 2019-01-25](https://www.globalkeysolutions.net/records/483/indoco-remedies-limited-plant-i/6817f714-58eb-49a0-bd22-621d560a785e)
- [483 - 2023-10-18](https://www.globalkeysolutions.net/records/483/indoco-remedies-limited-plant-i/827c9dfa-eba4-4c24-9439-1db2a1113374)

## Related Officers

- [Drug National Expert](https://www.globalkeysolutions.net/people/sandra-a-boyd/c469103a-0917-407a-b9d1-98273358dfeb)
- [Investigator](https://www.globalkeysolutions.net/people/kellia-n-hicks/44104c4a-70c1-47fc-9a77-c09c41bacc2b)

Company: https://www.globalkeysolutions.net/companies/indoco-remedies-limited-plant-i/cdf789a3-1db2-4bf5-92b5-d6771ea5df48

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