Evonik Rexim Nanning Pharmaceutical Co., Ltd.
Form 483 issued September 28, 2018 · Wuming District, China
- Inspection
- Sep 25 – Sep 28, 2018
- Investigator
- Steven P. Donald
- Observations
- 1
- Pages
- 1
In short: On September 28, 2018, FDA issued a Form 483 with 1 observation to Evonik Rexim Nanning Pharmaceutical Co., Ltd. in Wuming District, China after an inspection that ran Sep 25 – Sep 28, 2018. The investigator was Steven P. Donald. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.68 (1×) · 211.63 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
All utilities that could impact on product quality should be qualified and appropriately monitored and action…
This inspection in context
Steven P. Donald
4 documents · 2016–2018
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in China.
The firmEvonik Rexim Nanning Pharmaceutical Co., Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Evonik Rexim Nanning Pharmaceutical Co., Ltd.?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Evonik Rexim Nanning Pharmaceutical Co., Ltd.?
Steven P. Donald is named on this Form 483, for the inspection of Sep 25 – Sep 28, 2018. Each investigator has a profile showing what they cite most.
When was Evonik Rexim Nanning Pharmaceutical Co., Ltd. inspected by FDA?
The inspection ran Sep 25 – Sep 28, 2018, and the Form 483 is dated September 28, 2018.
How do I get the full Form 483 for Evonik Rexim Nanning Pharmaceutical 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.