BioMarin International Limited
FDA inspection history in Shanbally, Ireland, 2017
- 1
- Form 483
Every document, by year
- Form 483
2017: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2017One Form 483, at Shanbally, Ireland.
Cited most
Across all BioMarin International Limited observations on file
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.192Production record review1
- 21 CFR 211.67Equipment cleaning and maintenance1
The complete BioMarin International Limited file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Shanbally, Ireland
One Form 483 · 2017 · 3 observations
Latest: Form 483, May 2, 2017 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2017-05-02 | 483 Form 483 | Shanbally, Ireland | 3 | $99 |
Investigators on these documents
Gene Bo Chi (1)Gunther Bockhoudt (1)Kathleen R. Jones (1)Zhong Li (1)
FEI number 3010085632 · most recent document May 2, 2017
About BioMarin International Limited
How many FDA Form 483s has BioMarin International Limited received?
FDA Intel has 1 Form 483 on file for BioMarin International Limited; the most recent is dated May 2, 2017.
When was BioMarin International Limited last inspected by FDA?
The most recent FDA inspection document on file for BioMarin International Limited is a Form 483 dated May 2, 2017, for the site in Shanbally, Ireland.
What did FDA cite at BioMarin International Limited?
The regulations cited most in the observations on file for BioMarin International Limited are 21 CFR 211.113 (Control of microbiological contamination), 1 time; 21 CFR 211.192 (Production record review), 1 time; 21 CFR 211.67 (Equipment cleaning and maintenance), 1 time.