Astellas Pharma Technologies
FDA inspection history in Norman, Oklahoma, 2015
- 1
- Form 483
Every document, by year
- Form 483
2015: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015One Form 483, at Norman, Oklahoma.
Cited most
Across all Astellas Pharma Technologies observations on file
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.160General requirements1
- 21 CFR 211.192Production record review1
- 21 CFR 211.194Laboratory records1
- 21 CFR 211.22Responsibilities of quality control unit1
The complete Astellas Pharma Technologies file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Norman, Oklahoma
One Form 483 · 2015 · 7 observations
Latest: Form 483, Jun 24, 2015 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2015-06-24 | 483 Form 483 | Norman, Oklahoma | 7 | $99 |
Investigators on these documents
Cassandra L. Abellard (1)Walden H. Lee (1)William Leonard (1)
FEI number 3004998655 · most recent document Jun 24, 2015
About Astellas Pharma Technologies
How many FDA Form 483s has Astellas Pharma Technologies received?
FDA Intel has 1 Form 483 on file for Astellas Pharma Technologies; the most recent is dated Jun 24, 2015.
When was Astellas Pharma Technologies last inspected by FDA?
The most recent FDA inspection document on file for Astellas Pharma Technologies is a Form 483 dated Jun 24, 2015, for the site in Norman, Oklahoma.
What did FDA cite at Astellas Pharma Technologies?
The regulations cited most in the observations on file for Astellas Pharma Technologies are 21 CFR 211.100 (Written procedures; deviations), 1 time; 21 CFR 211.160 (General requirements), 1 time; 21 CFR 211.192 (Production record review), 1 time.