# Inventia Healthcare Limited – FDA 483, Jul 5, 2019

Source: https://www.keypedia.com/records/483/inventia-healthcare-limited/742874ed-6da9-4b77-9404-2b2568500c20

> FDA 483 for Inventia Healthcare Limited on July 05, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Inventia Healthcare Limited
- Inspection Date: 2019-07-05
- Product Type: drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: Inventia Healthcare Limited, a drug manufacturer in Thane, India, received an FDA Form 483 citing significant deficiencies in its quality control and manufacturing operations. The inspection revealed inadequate laboratory investigations for out-of-specification results, incomplete instrument calibration records, and insufficient data integrity controls for computer systems. Additionally, the firm failed to validate manufacturing processes and ensure proper training and qualification for personnel performing critical visual inspections.

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## Related Officers

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- [Investigator ](https://www.keypedia.com/people/nicole-e-knowlton/8e65400f-249f-45fe-96fc-cb00fec6ae39)

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

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c