ZvCUOlVe GY
Form 483 issued August 31, 2018 · Lianyungang City, China
- Inspection
- Aug 29 – Aug 31, 2018
- Investigator
- Jose E. Perez-Soto
- Observations
- 1
- Pages
- 2
- FEI number
- 2000019494
In short: On August 31, 2018, FDA issued a Form 483 with 1 observation to ZvCUOlVe GY in Lianyungang City, Jiangsu (FEI 2000019494) after an inspection that ran Aug 29 – Aug 31, 2018. The investigator was Jose E. Perez-Soto. Most observations concern dietary supplement CGMP; the most-cited regulation is 21 CFR 111.27 (what requirements apply to the equipment and utensils that you use?).
At a glance
1 of 1 observations on this 483 concern dietary supplement cgmp.
Most cited: 21 CFR 111.27 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your quality control personnel did not perform required operational tests. Specifically, on 07/05/2018, 08/28/2018, and 08/30/2018…
This inspection in context
Jose E. Perez-Soto
1 document · 2018
Cites 111.27 (what requirements apply to the equipment and utensils that you use?) more than any other section. Most of their documents are for sites in China.
The firmZvCUOlVe GY history
The site's inspection history, in date order.
Similar 483sOther sites cited under 111.27
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at ZvCUOlVe GY?
FDA listed 1 observation on this Form 483, mostly about dietary supplement CGMP. The most-cited regulation is 21 CFR 111.27 (what requirements apply to the equipment and utensils that you use?). The opening words of each observation are shown on this page.
Who inspected ZvCUOlVe GY?
Jose E. Perez-Soto is named on this Form 483, for the inspection of Aug 29 – Aug 31, 2018. Each investigator has a profile showing what they cite most.
When was ZvCUOlVe GY inspected by FDA?
The inspection ran Aug 29 – Aug 31, 2018, and the Form 483 is dated August 31, 2018.
How do I get the full Form 483 for ZvCUOlVe GY?
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.