# FDA 483 - Lavet Kft. - March 21, 2025

Source: https://www.globalkeysolutions.net/records/483/lavet-kft/eb82b2fe-6d59-4ab2-8982-f617b85896df

> FDA 483 for Lavet Kft. on March 21, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lavet Kft.
- Inspection Date: 2025-03-21
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Lavet Kft., a drug manufacturer in Kistarcsa, Hungary, was cited for significant GMP deficiencies during a pre-approval inspection. Observations included a lack of quality unit oversight on document control and data integrity issues with laboratory software, indicating a systemic failure in maintaining reliable records. Additionally, the firm failed to ensure stability-indicating test methods, properly retain reserve samples, and qualify manufacturing equipment.

## Related Officers

- [Pratik S. Upadhyay](https://www.globalkeysolutions.net/people/pratik-s-upadhyay/22ff2e0b-17d4-4c91-a3f0-c7e30b7a115b)

Company: https://www.globalkeysolutions.net/companies/lavet-kft/e02ff7db-bfb2-4448-bb1e-4281c6c05d42

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