Rohto-Mentholatum (Vietnam) Co., Ltd.
Form 483 issued March 16, 2018 · Thuan An, Vietnam
- Inspection
- Mar 8 – Mar 16, 2018
- Investigator
- Jose A. Cruz-Gonzalez
- Observations
- 14
- Pages
- 6
- FEI number
- 3008808745
In short: On March 16, 2018, FDA issued a Form 483 with 14 observations to Rohto-Mentholatum (Vietnam) Co., Ltd. in Thuan An, Vietnam (FEI 3008808745) after an inspection that ran Mar 8 – Mar 16, 2018. The investigator was Jose A. Cruz-Gonzalez. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and laboratory controls account for 12 of 14 observations.
Most cited: 21 CFR 211.113 (6×) · 211.160 (5×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Environmental monitoring procedures executed during the aseptic filling of OTC sterile drug products (i.e., roducts) currently…
- 02
Smoke studies executed to evaluate airflow patterns in the JING reduction Line…
- 03
The study conducted in 9/12 to qualify the MN eeeesre applied sin the Filling Room #…
- 04
The current firm’s procedure for the ithe Filling Room #[f@ document # SOP- PR-045/006 — “SOP…
This inspection in context
Jose A. Cruz-Gonzalez
11 documents · 2013–2019
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Puerto Rico.
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 211.113
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 14 observations on this Form 483, mostly about production, laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Rohto-Mentholatum (Vietnam) Co., Ltd.?
Jose A. Cruz-Gonzalez is named on this Form 483, for the inspection of Mar 8 – Mar 16, 2018. Each investigator has a profile showing what they cite most.
When was Rohto-Mentholatum (Vietnam) Co., Ltd. inspected by FDA?
The inspection ran Mar 8 – Mar 16, 2018, and the Form 483 is dated March 16, 2018.
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.