ASO Pharmaceutical Co.,ltd.
FDA inspection history in Kikuyomachi, Japan, 2023
- 1
- Form 483
Every document, by year
- Form 483
2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2023One Form 483, at Kikuyomachi, Japan.
Cited most
Across all ASO Pharmaceutical Co.,ltd. observations on file
- 21 CFR 211.100(a)Written procedures; deviations2
- 21 CFR 211.160(b)General requirements1
- 21 CFR 211.166(a)(4)Stability testing1
- 21 CFR 211.192Production record review1
- 21 CFR 211.42(a)Design and construction features1
The complete ASO Pharmaceutical Co.,ltd. file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Kikuyomachi, Japan
One Form 483 · 2023 · 6 observations
Latest: Form 483, Sep 8, 2023 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-09-08 | 483 Form 483 | Kikuyomachi, Japan | 6 | $99 |
Investigators on these documents
FEI number 1000414460 · most recent document Sep 8, 2023
About ASO Pharmaceutical Co.,ltd.
How many FDA Form 483s has ASO Pharmaceutical Co.,ltd. received?
FDA Intel has 1 Form 483 on file for ASO Pharmaceutical Co.,ltd.; the most recent is dated Sep 8, 2023.
When was ASO Pharmaceutical Co.,ltd. last inspected by FDA?
The most recent FDA inspection document on file for ASO Pharmaceutical Co.,ltd. is a Form 483 dated Sep 8, 2023, for the site in Kikuyomachi, Japan.
What did FDA cite at ASO Pharmaceutical Co.,ltd.?
The regulations cited most in the observations on file for ASO Pharmaceutical Co.,ltd. are 21 CFR 211.100(a) (Written procedures; deviations), 2 times; 21 CFR 211.160(b) (General requirements), 1 time; 21 CFR 211.166(a)(4) (Stability testing), 1 time.