# FDA 483 - Patheon Biologics B.V. - September 20, 2018

Source: https://www.globalkeysolutions.net/records/483/patheon-biologics-bv/90f4e084-b5ee-4500-b756-5833d59f3f2c

> FDA 483 for Patheon Biologics B.V. on September 20, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Patheon Biologics B.V.
- Inspection Date: 2018-09-20
- Product Type: drugs
- Office Name: Division of Advertising & Promotion 
- Summary: An FDA inspection of Patheon Biologics, B.V. in Groningen, Netherlands, a drug substance and drug product manufacturing facility, revealed numerous deficiencies. The findings indicate significant issues with the firm's quality systems, including inadequate deviation management, laboratory controls, written procedures, cleaning validation, and equipment/facility maintenance. These observations highlight a lack of control over critical manufacturing processes.

## Related Officers

- [Chen Sun](https://www.globalkeysolutions.net/people/chen-sun/f6a51adc-af97-4e40-aa07-eff034049750)
- [Patrick Lynch](https://www.globalkeysolutions.net/people/patrick-lynch/6bf2752f-4d19-4c56-9989-8434669809d9)
- [Senior Regulatory Specialist](https://www.globalkeysolutions.net/people/wayne-e-seifert/e92e1f10-c61e-4b08-9156-25907e5e2942)
- [Maria J. Lopez-Barragan](https://www.globalkeysolutions.net/people/maria-j-lopez-barragan/ff280946-0ba6-4416-89a2-4cda19d18dea)
- [investigator](https://www.globalkeysolutions.net/people/kathleen-r-jones/3760ffcd-ce90-4b7c-b0a6-726edc8264d8)

Company: https://www.globalkeysolutions.net/companies/patheon-biologics-bv/0eca08ab-09e7-4318-b843-4dda2116e17a

Office: https://www.globalkeysolutions.net/offices/division-of-advertising-promotion/adcc8282-aca9-4610-955c-e6553c7619b0