# FDA 483 - Indoco Remedies Limited (Plant I) - October 18, 2023

Source: https://www.globalkeysolutions.net/records/483/indoco-remedies-limited-plant-i/827c9dfa-eba4-4c24-9439-1db2a1113374

> FDA 483 for Indoco Remedies Limited (Plant I) on October 18, 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: 2023-10-18
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Indoco Remedies Limited (Plant I) in Verna Da Gama, Goa, India, was inspected and cited for significant deficiencies across its manufacturing operations. The inspection revealed failures in equipment cleaning and maintenance, inadequate visual inspection programs for drug products, and a lack of thorough investigation into out-of-specification results and discrepancies. Additionally, the firm's quality control unit demonstrated a failure to fully follow its procedures, impacting data integrity and record-keeping.

## 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 - 2023-01-20](https://www.globalkeysolutions.net/records/483/indoco-remedies-limited-plant-i/98381d61-704e-465e-8453-c84dc8652416)

## Related Officers

- [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