# FDA 483 - Inventia Healthcare Limited - February 12, 2025

Source: https://www.keypedia.com/records/483/inventia-healthcare-limited/d7c622ff-4348-4477-8816-fbd606c6dfd1

> FDA 483 for Inventia Healthcare Limited on February 12, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Inventia Healthcare Limited
- Inspection Date: 2025-02-12
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Inventia Healthcare Limited, a drug manufacturer in Thane, Maharashtra, India, was cited for significant quality control and manufacturing deficiencies during an FDA inspection. Observations included a failure to thoroughly investigate numerous unexplained discrepancies, out-of-specification results, and customer complaints, as well as issues with equipment design and maintenance. The firm also demonstrated a lack of adequate quality control unit authority in reviewing production records and insufficient controls over computer systems.

## Related Documents

- [483 - 2019-07-05](https://www.keypedia.com/records/483/inventia-healthcare-limited/0c5e555c-459d-45a8-b108-61dcde34e88e)

## Related Officers

- [Paranthaman Senthamarai Kannan](https://www.keypedia.com/people/paranthaman-senthamarai-kannan/12221263-b29b-4696-9e6e-84e659ae43cd)

Company: https://www.keypedia.com/companies/inventia-healthcare-limited/94a91531-3e83-4ace-87c1-2d79e18c350a

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8