BioMarin International Limited
Form 483 issued May 2, 2017 · Shanbally, Ireland
- Inspection
- Apr 24 – May 2, 2017
- Investigators
- Gene Bo Chi· Gunther Bockhoudt· Kathleen R. Jones
- Observations
- 3
- Pages
- 1
- FEI number
- 3010085632
In short: On May 2, 2017, FDA issued a Form 483 with 3 observations to BioMarin International Limited in Shanbally, RINGASKIDDY (FEI 3010085632) after an inspection that ran Apr 24 – May 2, 2017. The investigators were Gene Bo Chi, Gunther Bockhoudt, Kathleen R. Jones and Zhong Li. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and production account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Investigation of deviation 88878…
- 02
Microbial control of the , skid (11@'-192-01) of the , drug Isubstance…
- 03
There is no protocol in place to verify the effectiveness of the solution during storage a…
This inspection in context
Gene Bo Chi
1 document · 2017
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Ireland.
The firmBioMarin International Limited 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 BioMarin International Limited?
FDA listed 3 observations on this Form 483, mostly about quality system, production and facilities & equipment. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected BioMarin International Limited?
Gene Bo Chi, Gunther Bockhoudt, Kathleen R. Jones and Zhong Li are named on this Form 483, for the inspection of Apr 24 – May 2, 2017. Each investigator has a profile showing what they cite most.
When was BioMarin International Limited inspected by FDA?
The inspection ran Apr 24 – May 2, 2017, and the Form 483 is dated May 2, 2017.
How do I get the full Form 483 for BioMarin International Limited?
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.