Astellas Pharma Inc.
FDA inspection history in Takaoka, Japan, 2019 to 2025
- 2
- Form 483s
Every document, by year
- Form 483
2019: one Form 483; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019One Form 483, at Takaoka, Japan.
- 2019The longest 483 on file: 8 observations over 8 pages at Takaoka, Japan.
- 2025One Form 483, at Takaoka, Japan.
Cited most
Across all Astellas Pharma observations on file
- 21 CFR 211.110(a)Sampling and testing of in-process materials and drug products2
- 21 CFR 211.113(b)Control of microbiological contamination2
- 21 CFR 211.100(a)Written procedures; deviations1
- 21 CFR 211.160(b)General requirements1
- 21 CFR 211.170(b)Reserve samples1
The complete Astellas Pharma file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Takaoka, Japan
Two Form 483s · 2019 to 2025 · 10 observations
Latest: Form 483, Jun 6, 2025 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-06-06 | 483 Form 483 | Takaoka, Japan | 2 | $99 |
| 2019-03-05 | 483 Form 483 | Takaoka, Japan | 8 | $99 |
Investigators on these documents
FEI number 3002807001 · most recent document Jun 6, 2025
About Astellas Pharma Inc.
How many FDA Form 483s has Astellas Pharma Inc. received?
FDA Intel has 2 Form 483s on file for Astellas Pharma Inc.; the most recent is dated Jun 6, 2025.
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 Jun 6, 2025, for the site in Takaoka, 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 211.110(a) (Sampling and testing of in-process materials and drug products), 2 times; 21 CFR 211.113(b) (Control of microbiological contamination), 2 times; 21 CFR 211.100(a) (Written procedures; deviations), 1 time.