Astellas Pharma Inc.
Form 483 issued October 27, 2023 · Yaizu, Japan
- Inspection
- Oct 23 – Oct 27, 2023
- Investigator
- Michele Gottshall
- Observations
- 1
- Pages
- 1
- FEI number
- 3002809620
In short: On October 27, 2023, FDA issued a Form 483 with 1 observation to Astellas Pharma Inc. in Yaizu, Shizuoka (FEI 3002809620) after an inspection that ran Oct 23 – Oct 27, 2023. The investigator was Michele Gottshall. Most observations concern quality system; the most-cited regulation is 21 CFR 211.198 (complaint files).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.198(b)(2) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Complaint records are deficient in that they do not…
This inspection in context
Michele Gottshall
12 documents · 2020–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmAstellas Pharma Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.198(b)(2)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Astellas Pharma Inc.?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.198 (complaint files). The opening words of each observation are shown on this page.
Who inspected Astellas Pharma Inc.?
Michele Gottshall is named on this Form 483, for the inspection of Oct 23 – Oct 27, 2023. Each investigator has a profile showing what they cite most.
When was Astellas Pharma Inc. inspected by FDA?
The inspection ran Oct 23 – Oct 27, 2023, and the Form 483 is dated October 27, 2023.
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.