Mentholatum (China) Pharmaceuticals Co., Ltd.
Form 483 issued June 21, 2019 · Zhongshan, China
- Inspection
- Jun 17 – Jun 21, 2019
- Investigator
- Uttaniti Limchumroon
- Observations
- 2
- Pages
- 2
- FEI number
- 3000188423
In short: On June 21, 2019, FDA issued a Form 483 with 2 observations to Mentholatum (China) Pharmaceuticals Co., Ltd. in Zhongshan, Guangdong (FEI 3000188423) after an inspection that ran Jun 17 – Jun 21, 2019. The investigator was Uttaniti Limchumroon. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.160(b) (1×) · 211.192 (1×)
What FDA observed
Preview: the opening words of each observation- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
This inspection in context
Uttaniti Limchumroon
20 documents · 2015–2021
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmMentholatum (China) Pharmaceuticals Co., Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.160(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Mentholatum (China) Pharmaceuticals Co., Ltd.?
FDA listed 2 observations on this Form 483, mostly about laboratory controls and quality system. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Mentholatum (China) Pharmaceuticals Co., Ltd.?
Uttaniti Limchumroon is named on this Form 483, for the inspection of Jun 17 – Jun 21, 2019. Each investigator has a profile showing what they cite most.
When was Mentholatum (China) Pharmaceuticals Co., Ltd. inspected by FDA?
The inspection ran Jun 17 – Jun 21, 2019, and the Form 483 is dated June 21, 2019.
How do I get the full Form 483 for Mentholatum (China) Pharmaceuticals Co., Ltd.?
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