Rohto Pharmaceutical Co., Ltd.
FDA inspection history in Iga, 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 Iga, Japan.
Cited most
Across all Rohto Pharmaceutical Co. observations on file
- 21 CFR 211.100Written procedures; deviations2
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.160General requirements1
- 21 CFR 211.180General requirements1
- 21 CFR 211.198Complaint files1
The complete Rohto Pharmaceutical Co. file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Iga, Japan
One Form 483 · 2023 · 6 observations
Latest: Form 483, Mar 8, 2023 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-03-08 | 483 Form 483 | Iga, Japan | 6 | $99 |
Investigators on these documents
FEI number 3003722237 · most recent document Mar 8, 2023
About Rohto Pharmaceutical Co., Ltd.
How many FDA Form 483s has Rohto Pharmaceutical Co., Ltd. received?
FDA Intel has 1 Form 483 on file for Rohto Pharmaceutical Co., Ltd.; the most recent is dated Mar 8, 2023.
When was Rohto Pharmaceutical Co., Ltd. last inspected by FDA?
The most recent FDA inspection document on file for Rohto Pharmaceutical Co., Ltd. is a Form 483 dated Mar 8, 2023, for the site in Iga, Japan.
What did FDA cite at Rohto Pharmaceutical Co., Ltd.?
The regulations cited most in the observations on file for Rohto Pharmaceutical Co., Ltd. are 21 CFR 211.100 (Written procedures; deviations), 2 times; 21 CFR 211.113 (Control of microbiological contamination), 1 time; 21 CFR 211.160 (General requirements), 1 time.