Patheon Biologics B.V.
Form 483 issued February 13, 2018 · Groningen, Netherlands
- Inspection
- Feb 5 – Feb 13, 2018
- Investigators
- Oa C. Barragan· Patrick Lynch· Ravens A. Barragan
- Observations
- 10
- Pages
- 5
- FEI number
- 3002608687
In short: On February 13, 2018, FDA issued a Form 483 with 10 observations to Patheon Biologics B.V. in Groningen, Netherlands (FEI 3002608687) after an inspection that ran Feb 5 – Feb 13, 2018. The investigators were Oa C. Barragan, Patrick Lynch, Ravens A. Barragan, Ve -. Barragan, Vere Le X. Barragan and Wayne Seifert. Most observations concern quality system and facilities & equipment.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Deviation procedures and deviation…
- 02
Laboratory controls are inadequate to ensure quality of…
- 03
Written procedures are…
- 04
Cleaning validation of critical equipment used in the manufacture of…
This inspection in context
Oa C. Barragan
1 document · 2018
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Netherlands.
The firmPatheon Biologics B.V. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Patheon Biologics B.V.?
FDA listed 10 observations on this Form 483, mostly about quality system, facilities & equipment and materials. The opening words of each observation are shown on this page.
Who inspected Patheon Biologics B.V.?
Oa C. Barragan, Patrick Lynch, Ravens A. Barragan, Ve -. Barragan, Vere Le X. Barragan and Wayne Seifert are named on this Form 483, for the inspection of Feb 5 – Feb 13, 2018. Each investigator has a profile showing what they cite most.
When was Patheon Biologics B.V. inspected by FDA?
The inspection ran Feb 5 – Feb 13, 2018, and the Form 483 is dated February 13, 2018.
How do I get the full Form 483 for Patheon Biologics B.V.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.