FDA Form 483 Ultragenyx Pharmaceutical Inc, Bedford, MA April 2025
Form 483 issued April 25, 2025 · Bedford, Massachusetts
- Inspection
- Apr 21 – Apr 25, 2025
- Investigators
- Jacob L. Bitterman· Kula Jha· Massoud Motamed
- Observations
- 6
- Pages
- 7
- FEI number
- 3025268614
In short: On April 25, 2025, FDA issued a Form 483 with 6 observations to FDA Form 483 Ultragenyx Pharmaceutical Inc, Bedford, MA April 2025 in Bedford, Massachusetts (FEI 3025268614) after an inspection that ran Apr 21 – Apr 25, 2025. The investigators were Jacob L. Bitterman, Kula Jha, Massoud Motamed and Timothy Kamaldinov. 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 5 of 6 observations.
Most cited: 21 CFR 211.192 (2×) · 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The integrity of data via…
- 02
Documentation and/or maintenance of buildings and facilities used in the manufacture of viral vector drug products…
- 03
Deviation management is inadequate to demonstrate quality oversight of the manufacturing process and does not adequately…
- 04
Quality oversight is deficient to assure drug product has the identity, strength, quality, and purity it…
This inspection in context
Jacob L. Bitterman
1 document · 2025
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Massachusetts.
The firmFDA Form 483 Ultragenyx Pharmaceutical Inc, Bedford, MA April 2025 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 FDA Form 483 Ultragenyx Pharmaceutical Inc, Bedford, MA April 2025?
FDA listed 6 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 FDA Form 483 Ultragenyx Pharmaceutical Inc, Bedford, MA April 2025?
Jacob L. Bitterman, Kula Jha, Massoud Motamed and Timothy Kamaldinov are named on this Form 483, for the inspection of Apr 21 – Apr 25, 2025. Each investigator has a profile showing what they cite most.
When was FDA Form 483 Ultragenyx Pharmaceutical Inc, Bedford, MA April 2025 inspected by FDA?
The inspection ran Apr 21 – Apr 25, 2025, and the Form 483 is dated April 25, 2025.
How do I get the full Form 483 for FDA Form 483 Ultragenyx Pharmaceutical Inc, Bedford, MA April 2025?
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.