Astellas Pharma Inc.
Form 483 issued June 6, 2025 · Takaoka, Japan
- Inspection
- Jun 2 – Jun 6, 2025
- Investigator
- Bijoy Panicker
- Observations
- 2
- Pages
- 2
- FEI number
- 3002807001
In short: On June 6, 2025, FDA issued a Form 483 with 2 observations to Astellas Pharma Inc. in Takaoka, Toyama (FEI 3002807001) after an inspection that ran Jun 2 – Jun 6, 2025. The investigator was Bijoy Panicker. Most observations concern production; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
2 of 2 observations on this 483 concern production.
Most cited: 21 CFR 211.100(a) (1×) · 211.113(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
- 02
Procedures designed to prevent microbiological contamination of ding products purporting to be sterile did not include…
This inspection in context
Bijoy Panicker
34 documents · 2017–2025
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New York.
The firmAstellas Pharma Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Astellas Pharma Inc.?
FDA listed 2 observations on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Astellas Pharma Inc.?
Bijoy Panicker 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 Astellas Pharma Inc. 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 Astellas Pharma Inc.?
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.