FDA Form 483 Takeda Pharmaceutical, Longmont, CO June 2025
Form 483 issued June 6, 2025 · Longmont, Colorado
- Inspection
- Jun 2 – Jun 6, 2025
- Investigator
- David A. Moore
- Observations
- 1
- Pages
- 3
In short: On June 6, 2025, FDA issued a Form 483 with 1 observation to FDA Form 483 Takeda Pharmaceutical, Longmont, CO June 2025 in Longmont, Colorado after an inspection that ran Jun 2 – Jun 6, 2025. The investigator was David A. Moore. Most observations concern biologics CGMP; the most-cited regulation is 21 CFR 606.60 (equipment).
At a glance
1 of 1 observations on this 483 concern biologics cgmp.
Most cited: 21 CFR 606.60 (1×) · 606.100 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment used in the collection and processing of blood and blood components is not standardized and…
This inspection in context
David A. Moore
1 document · 2025
Cites 606.100 (standard operating procedures) more than any other section. Most of their documents are for sites in Colorado.
The firmFDA Form 483 Takeda Pharmaceutical, Longmont, CO June 2025 history
The site's inspection history, in date order.
Similar 483sOther sites cited under 606.60
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at FDA Form 483 Takeda Pharmaceutical, Longmont, CO June 2025?
FDA listed 1 observation on this Form 483, mostly about biologics CGMP. The most-cited regulation is 21 CFR 606.60 (equipment). The opening words of each observation are shown on this page.
Who inspected FDA Form 483 Takeda Pharmaceutical, Longmont, CO June 2025?
David A. Moore is named on this Form 483, for the inspection of Jun 2 – Jun 6, 2025. Each investigator has a profile showing what they cite most.
When was FDA Form 483 Takeda Pharmaceutical, Longmont, CO June 2025 inspected by FDA?
The inspection ran Jun 2 – Jun 6, 2025, and the Form 483 is dated June 6, 2025.
How do I get the full Form 483 for FDA Form 483 Takeda Pharmaceutical, Longmont, CO June 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.