Astellas Pharma Inc.
Form 483 issued October 7, 2019 · Toyama, Japan
- Inspection
- Sep 30 – Oct 7, 2019
- Investigators
- Jacek Cieslak· Maxwell Van Tassell· Michael R. Shanks
- Observations
- 2
- Pages
- 1
- FEI number
- 3002807003
In short: On October 7, 2019, FDA issued a Form 483 with 2 observations to Astellas Pharma Inc. in Toyama, Toyama (FEI 3002807003) after an inspection that ran Sep 30 – Oct 7, 2019. The investigators were Jacek Cieslak, Maxwell Van Tassell and Michael R. Shanks. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products).
At a glance
Quality system and production account for 2 of 2 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written procedures for documenting the use of critical…
- 02
Procedural controls for the handling and documentation of…
This inspection in context
Jacek Cieslak
6 documents · 2019–2023
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Japan.
The firmAstellas Pharma Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.182
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 quality system and production. The most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products). The opening words of each observation are shown on this page.
Who inspected Astellas Pharma Inc.?
Jacek Cieslak, Maxwell Van Tassell and Michael R. Shanks are named on this Form 483, for the inspection of Sep 30 – Oct 7, 2019. Each investigator has a profile showing what they cite most.
When was Astellas Pharma Inc. inspected by FDA?
The inspection ran Sep 30 – Oct 7, 2019, and the Form 483 is dated October 7, 2019.
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.