Shandong Ruiying Pioneer Pharmaceutical Co., Ltd.
Form 483 issued March 22, 2019 · Heze City, China
- Inspection
- Mar 18 – Mar 22, 2019
- Investigator
- Yiming Zhang
- Observations
- 2
- Pages
- 1
- FEI number
- 3008320758
In short: On March 22, 2019, FDA issued a Form 483 with 2 observations to Shandong Ruiying Pioneer Pharmaceutical Co., Ltd. in Heze City, Shandong (FEI 3008320758) after an inspection that ran Mar 18 – Mar 22, 2019. The investigator was Yiming Zhang. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.56 (sanitation).
At a glance
Observations span 1 system, led by facilities & equipment.
Most cited: 21 CFR 211.56 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
sed in the manufacturing of PO…
- 02
2. Your firm’s warehouse cleaning practice is deficient in that not all warehouse storage rooms were…
This inspection in context
Yiming Zhang
1 document · 2019
Cites 211.56 (sanitation) more than any other section. Most of their documents are for sites in China.
The firmShandong Ruiying Pioneer Pharmaceutical Co., Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.56
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Shandong Ruiying Pioneer Pharmaceutical Co., Ltd.?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.56 (sanitation). The opening words of each observation are shown on this page.
Who inspected Shandong Ruiying Pioneer Pharmaceutical Co., Ltd.?
Yiming Zhang is named on this Form 483, for the inspection of Mar 18 – Mar 22, 2019. Each investigator has a profile showing what they cite most.
When was Shandong Ruiying Pioneer Pharmaceutical Co., Ltd. inspected by FDA?
The inspection ran Mar 18 – Mar 22, 2019, and the Form 483 is dated March 22, 2019.
How do I get the full Form 483 for Shandong Ruiying Pioneer 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.