Rohto-Mentholatum (Vietnam) Co., Ltd.
FDA inspection history in Thuan An, Vietnam, 2018 to 2026
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Warning letter
- Form 483
2018: one Form 483; 2019: one Form 483; 2026: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2018–19Two Form 483s, at Thuan An, Vietnam.
- 2018The longest 483 on file: 14 observations over 6 pages at Thuan An, Vietnam.
- 2026One warning letter.
Cited most
Across all Rohto-Mentholatum (Vietnam) Co. observations on file
- 21 CFR 211.113Control of microbiological contamination6
- 21 CFR 211.160General requirements6
- 21 CFR 211.42Design and construction features3
- 21 CFR 211.100Written procedures; deviations2
- 21 CFR 211.192Production record review1
The complete Rohto-Mentholatum (Vietnam) 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
Thuan An, Vietnam
Two Form 483s · 2018 to 2019 · 20 observations
Latest: Form 483, Nov 1, 2019 →
Also: one document not tied to a site.
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-10-14 | Warning letter Warning letter | — | — | $99 |
| 2019-11-01 | 483 Form 483 | Thuan An, Vietnam | 6 | $99 |
| 2018-03-16 | 483 Form 483 | Thuan An, Vietnam | 14 | $99 |
Investigators on these documents
FEI number 3008808745 · most recent document Oct 14, 2026
About Rohto-Mentholatum (Vietnam) Co., Ltd.
How many FDA Form 483s has Rohto-Mentholatum (Vietnam) Co., Ltd. received?
FDA Intel has 2 Form 483s on file for Rohto-Mentholatum (Vietnam) Co., Ltd.; the most recent is dated Nov 1, 2019.
When was Rohto-Mentholatum (Vietnam) Co., Ltd. last inspected by FDA?
The most recent FDA inspection document on file for Rohto-Mentholatum (Vietnam) Co., Ltd. is a Form 483 dated Nov 1, 2019, for the site in Thuan An, Vietnam.
What did FDA cite at Rohto-Mentholatum (Vietnam) Co., Ltd.?
The regulations cited most in the observations on file for Rohto-Mentholatum (Vietnam) Co., Ltd. are 21 CFR 211.113 (Control of microbiological contamination), 6 times; 21 CFR 211.160 (General requirements), 6 times; 21 CFR 211.42 (Design and construction features), 3 times.
Has Rohto-Mentholatum (Vietnam) Co., Ltd. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Rohto-Mentholatum (Vietnam) Co., Ltd.; the most recent is dated Oct 14, 2026.