# FDA 483 - Pharbil Waltrop Gmbh - June 06, 2025

Source: https://www.keypedia.com/records/483/pharbil-waltrop-gmbh/03ff22ea-a3b6-449c-8282-241b63a1c29d

> FDA 483 for Pharbil Waltrop Gmbh on June 06, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pharbil Waltrop Gmbh
- Inspection Date: 2025-06-06
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Pharbil Waltrop Gmbh in Waltrop, Germany, revealed significant deficiencies in the firm's manufacturing and quality control systems. Observations included incomplete batch production records, specifically regarding product reconciliation, and a failure of the quality unit to detect discrepancies in test data between laboratory journals and certificates of analysis. These findings indicate a lack of adequate control over critical production and quality processes.

## Related Documents

- [483 - 2020-02-14](https://www.keypedia.com/records/483/pharbil-waltrop-gmbh/6e22f962-0a56-4158-b4f6-d3f0b959c62a)
- [483 - 2025-06-06](https://www.keypedia.com/records/483/pharbil-waltrop-gmbh/18a8a34b-7202-41c3-a49e-ec7e83416110)

## Related Officers

- [Youkeun Kim](https://www.keypedia.com/people/youkeun-kim/94ccfde4-72f7-4df1-9c68-ede73e5e23d0)

Company: https://www.keypedia.com/companies/pharbil-waltrop-gmbh/f3455dea-04cf-4c53-ab8b-3fcddc45fb4c

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