Astellas Pharma Inc.
FDA inspection history in Toyama, Japan, 2019
- 1
- Form 483
Every document, by year
- Form 483
2019: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019One Form 483, at Toyama, Japan.
Cited most
Across all Astellas Pharma observations on file
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.110Sampling and testing of in-process materials and drug products1
- 21 CFR 211.182Equipment cleaning and use log1
The complete Astellas Pharma file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Toyama, Japan
One Form 483 · 2019 · 2 observations
Latest: Form 483, Oct 7, 2019 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-10-07 | 483 Form 483 | Toyama, Japan | 2 | $99 |
Investigators on these documents
Jacek Cieslak (1)Maxwell Van Tassell (1)Michael R. Shanks (1)
FEI number 3002807003 · most recent document Oct 7, 2019
About Astellas Pharma Inc.
How many FDA Form 483s has Astellas Pharma Inc. received?
FDA Intel has 1 Form 483 on file for Astellas Pharma Inc.; the most recent is dated Oct 7, 2019.
When was Astellas Pharma Inc. last inspected by FDA?
The most recent FDA inspection document on file for Astellas Pharma Inc. is a Form 483 dated Oct 7, 2019, for the site in Toyama, Japan.
What did FDA cite at Astellas Pharma Inc.?
The regulations cited most in the observations on file for Astellas Pharma Inc. are 21 CFR 211.100 (Written procedures; deviations), 1 time; 21 CFR 211.110 (Sampling and testing of in-process materials and drug products), 1 time; 21 CFR 211.182 (Equipment cleaning and use log), 1 time.