# FDA 483 - Pharbil Waltrop Gmbh - February 14, 2020

Source: https://www.globalkeysolutions.net/records/483/pharbil-waltrop-gmbh/6e22f962-0a56-4158-b4f6-d3f0b959c62a

> FDA 483 for Pharbil Waltrop Gmbh on February 14, 2020. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Pharbil Waltrop Gmbh
- Inspection Date: 2020-02-14
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Pharbil Waltrop Gmbh in Waltrop, Germany, revealed significant deficiencies in manufacturing process controls. The firm failed to establish adequate control procedures for monitoring manufacturing processes, including insufficient drug product sampling plans and uncontrolled labels for samples. Additionally, the company did not determine actual or theoretical yields at the conclusion of manufacturing phases, hindering the recognition and investigation of production deviations.

## Related Documents

- [483 - 2025-06-06](https://www.globalkeysolutions.net/records/483/pharbil-waltrop-gmbh/03ff22ea-a3b6-449c-8282-241b63a1c29d)

## Related Officers

- [Russell J. Glapion](https://www.globalkeysolutions.net/people/russell-j-glapion/54dd6274-563a-44fe-8016-2ebd700be7a0)

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

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1