Alps Pharmaceutical Ind. Co., Ltd.
FDA inspection history across 3 sites, 2010 to 2023
- 3
- Form 483s
Every document, by year
- Form 483
2010: one Form 483; 2019: one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2010One Form 483, at Hida City, Japan.
- 2019One Form 483, at Hida, Japan.
- 2023One Form 483, at Hida-shi, Japan.
- 2023The longest 483 on file: 3 observations over 2 pages at Hida-shi, Japan.
Cited most
Across all Alps Pharmaceutical Ind. Co. observations on file
- 21 CFR 211.67Equipment cleaning and maintenance3
- 21 CFR 211.160General requirements2
- 21 CFR 211.194Laboratory records1
- 21 CFR 211.68Automatic, mechanical, and electronic equipment1
The complete Alps Pharmaceutical Ind. Co. file.
All 3 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
Hida-shi, Japan
One Form 483 · 2023 · 3 observations
Latest: Form 483, May 26, 2023 →Hida, Japan
One Form 483 · 2019 · 2 observations
Latest: Form 483, Apr 5, 2019 →Hida City, Japan
One Form 483 · 2010 · 2 observations
Latest: Form 483, Oct 13, 2010 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-05-26 | 483 Form 483 | Hida-shi, Japan | 3 | $99 |
| 2019-04-05 | 483 Form 483 | Hida, Japan | 2 | $99 |
| 2010-10-13 | 483 Form 483 | Hida City, Japan | 2 | $99 |
Investigators on these documents
FEI number 3002806352 · most recent document May 26, 2023
About Alps Pharmaceutical Ind. Co., Ltd.
How many FDA Form 483s has Alps Pharmaceutical Ind. Co., Ltd. received?
FDA Intel has 3 Form 483s on file for Alps Pharmaceutical Ind. Co., Ltd.; the most recent is dated May 26, 2023.
When was Alps Pharmaceutical Ind. Co., Ltd. last inspected by FDA?
The most recent FDA inspection document on file for Alps Pharmaceutical Ind. Co., Ltd. is a Form 483 dated May 26, 2023, for the site in Hida-shi, Japan.
What did FDA cite at Alps Pharmaceutical Ind. Co., Ltd.?
The regulations cited most in the observations on file for Alps Pharmaceutical Ind. Co., Ltd. are 21 CFR 211.67 (Equipment cleaning and maintenance), 3 times; 21 CFR 211.160 (General requirements), 2 times; 21 CFR 211.194 (Laboratory records), 1 time.