# FDA 483 - Finecure Pharmaceuticals Limited - November 22, 2024

Source: https://www.keypedia.com/records/483/finecure-pharmaceuticals-limited/0f3a5060-ad39-49f4-8cab-1901cd453367

> FDA 483 for Finecure Pharmaceuticals Limited on November 22, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Finecure Pharmaceuticals Limited
- Inspection Date: 2024-11-22
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Finecure Pharmaceuticals Limited in Ahmedabad, India, revealed a significant deficiency in their drug product stability program. The firm was cited for using a non-stability-indicating test method for assay of stability samples, which failed to analyze component degradation or impurities. This issue impacts the reliability of their stability testing, for which they are responsible under a quality agreement with their U.S. distributor.

## Related Officers

- [ Drug Investigator](https://www.keypedia.com/people/tekalign-wondimu/3b80e5c8-4062-4e1d-8ddd-b1afa2616dec)

Company: https://www.keypedia.com/companies/finecure-pharmaceuticals-limited/25a2848f-98fb-45ce-b50f-269e56524bd1

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