# FDA 483 - Inventaa Chemicals Private Limited - September 19, 2025

Source: https://www.keypedia.com/records/483/inventaa-chemicals-private-limited/c179cde9-77c2-4d19-9aa7-08ce64a7ed23

> FDA 483 for Inventaa Chemicals Private Limited on September 19, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Inventaa Chemicals Private Limited
- Inspection Date: 2025-09-19
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Inventaa Chemicals Private Limited, an API manufacturer in Bodavada, India, was cited for significant deficiencies across its quality system. Observations included widespread data integrity issues, a lack of adequate quality unit oversight in areas like investigations and document control, and failures in supplier approval and equipment maintenance. These issues indicate a systemic breakdown in CGMP compliance.

## Related Officers

- [Investigator](https://www.keypedia.com/people/clinton-j-lott/ac4c7d18-13fd-4b1b-b2a1-06794c9960c7)
- [Investigator](https://www.keypedia.com/people/karishma-g-gopaul/ec5be791-b76c-4a31-bbed-9395e576d2c3)

Company: https://www.keypedia.com/companies/inventaa-chemicals-private-limited/96eef88f-d778-4c81-a9b4-8fca39a1e555

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