FDA Form 483 Ultragenyx Pharmaceutical Inc, Bedford, MA April 2025
FDA inspection history in Bedford, Massachusetts, 2025
- 1
- Form 483
Every document, by year
- Form 483
2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2025One Form 483, at Bedford, Massachusetts.
Cited most
Across all FDA Form 483 Ultragenyx Pharmaceutical Inc, Bedford, MA April 2025 observations on file
- 21 CFR 211.113Control of microbiological contamination2
- 21 CFR 211.192Production record review2
- 21 CFR 211.180General requirements1
- 21 CFR 211.22Responsibilities of quality control unit1
- 21 CFR 211.42Design and construction features1
The complete FDA Form 483 Ultragenyx Pharmaceutical Inc, Bedford, MA April 2025 file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Bedford, Massachusetts
One Form 483 · 2025 · 6 observations
Latest: Form 483, Apr 25, 2025 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-04-25 | 483 Form 483 | Bedford, Massachusetts | 6 | $99 |
Investigators on these documents
Jacob L. Bitterman (1)Kula Jha (1)Massoud Motamed (1)Timothy Kamaldinov (1)
FEI number 3025268614 · most recent document Apr 25, 2025
About FDA Form 483 Ultragenyx Pharmaceutical Inc, Bedford, MA April 2025
How many FDA Form 483s has FDA Form 483 Ultragenyx Pharmaceutical Inc, Bedford, MA April 2025 received?
FDA Intel has 1 Form 483 on file for FDA Form 483 Ultragenyx Pharmaceutical Inc, Bedford, MA April 2025; the most recent is dated Apr 25, 2025.
When was FDA Form 483 Ultragenyx Pharmaceutical Inc, Bedford, MA April 2025 last inspected by FDA?
The most recent FDA inspection document on file for FDA Form 483 Ultragenyx Pharmaceutical Inc, Bedford, MA April 2025 is a Form 483 dated Apr 25, 2025, for the site in Bedford, Massachusetts.
What did FDA cite at FDA Form 483 Ultragenyx Pharmaceutical Inc, Bedford, MA April 2025?
The regulations cited most in the observations on file for FDA Form 483 Ultragenyx Pharmaceutical Inc, Bedford, MA April 2025 are 21 CFR 211.113 (Control of microbiological contamination), 2 times; 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.180 (General requirements), 1 time.