Rohto-Mentholatum (Vietnam) Co., Ltd.
Form 483 issued November 1, 2019 · Thuan An, Vietnam
- Inspection
- Oct 24 – Nov 1, 2019
- Investigator
- Bijoy Panicker
- Observations
- 6
- Pages
- 4
- FEI number
- 3008808745
In short: On November 1, 2019, FDA issued a Form 483 with 6 observations to Rohto-Mentholatum (Vietnam) Co., Ltd. in Thuan An, Vietnam (FEI 3008808745) after an inspection that ran Oct 24 – Nov 1, 2019. The investigator was Bijoy Panicker. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 4 of 6 observations.
Most cited: 21 CFR 211.42 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Aseptic processing areas are deficient regarding the system…
- 02
There are no written procedures for production and process controls designed to assure that the drug…
- 03
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 04
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
This inspection in context
Bijoy Panicker
34 documents · 2017–2025
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New York.
The firmRohto-Mentholatum (Vietnam) Co., Ltd. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Rohto-Mentholatum (Vietnam) Co., Ltd.?
FDA listed 6 observations on this Form 483, mostly about facilities & equipment, production and quality system. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Rohto-Mentholatum (Vietnam) Co., Ltd.?
Bijoy Panicker is named on this Form 483, for the inspection of Oct 24 – Nov 1, 2019. Each investigator has a profile showing what they cite most.
When was Rohto-Mentholatum (Vietnam) Co., Ltd. inspected by FDA?
The inspection ran Oct 24 – Nov 1, 2019, and the Form 483 is dated November 1, 2019.
How do I get the full Form 483 for Rohto-Mentholatum (Vietnam) Co., Ltd.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.