BioMarin Pharmaceutical Inc.
FDA inspection history in Novato, California, 2021 to 2022
- 2
- Form 483s
Every document, by year
- Form 483
2021: one Form 483; 2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2021–22Two Form 483s, at Novato, California.
- 2022The longest 483 on file: 2 observations over 3 pages at Novato, California.
Cited most
Across all BioMarin Pharmaceutical observations on file
- 21 CFR 211.160General requirements2
- 21 CFR 211.100Written procedures; deviations1
The complete BioMarin Pharmaceutical file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Novato, California
Two Form 483s · 2021 to 2022 · 2 observations
Latest: Form 483, Dec 9, 2022 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-12-09 | 483 Form 483 | Novato, California | 2 | $99 |
| 2021-04-02 | 483 Form 483 | Novato, California | — | $99 |
Investigators on these documents
Andrew Harmon (1)Emmanuel Adu-Gyamfi (1)Kula Jha (1)Laura Fontan (1)Thomas R. Withers (1)Uttaniti Limchumroon (1)
FEI number 3004079983 · most recent document Dec 9, 2022
About BioMarin Pharmaceutical Inc.
How many FDA Form 483s has BioMarin Pharmaceutical Inc. received?
FDA Intel has 2 Form 483s on file for BioMarin Pharmaceutical Inc.; the most recent is dated Dec 9, 2022.
When was BioMarin Pharmaceutical Inc. last inspected by FDA?
The most recent FDA inspection document on file for BioMarin Pharmaceutical Inc. is a Form 483 dated Dec 9, 2022, for the site in Novato, California.
What did FDA cite at BioMarin Pharmaceutical Inc.?
The regulations cited most in the observations on file for BioMarin Pharmaceutical Inc. are 21 CFR 211.160 (General requirements), 2 times; 21 CFR 211.100 (Written procedures; deviations), 1 time.