# FDA 483 - Indoco Remedies Limited (Plant I) - January 25, 2019

Source: https://www.globalkeysolutions.net/records/483/indoco-remedies-limited-plant-i/6817f714-58eb-49a0-bd22-621d560a785e

> FDA 483 for Indoco Remedies Limited (Plant I) on January 25, 2019. 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: 2019-01-25
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Indoco Remedies Limited (Plant I) in Vasco Da Gama, Goa, a tablet manufacturer, was inspected and cited for significant data integrity issues and inadequate quality control. Observations included purposeful recording of inaccurate manufacturing data, failure to thoroughly investigate discrepancies and OOS results, and incomplete laboratory and batch records. The inspection revealed systemic problems in data management, record-keeping, and procedural adherence.

## 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 - 2023-01-20](https://www.globalkeysolutions.net/records/483/indoco-remedies-limited-plant-i/98381d61-704e-465e-8453-c84dc8652416)
- [483 - 2023-10-18](https://www.globalkeysolutions.net/records/483/indoco-remedies-limited-plant-i/827c9dfa-eba4-4c24-9439-1db2a1113374)

## Related Officers

- [Research Specialist II](https://www.globalkeysolutions.net/people/justin-a-boyd/796c9c9d-02db-486c-bdca-cc259066a0e2)
- [Compliance Officer](https://www.globalkeysolutions.net/people/rumany-c-penn/021eb1e0-8de0-403f-9596-3e76624b2e5a)

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