Chifeng Pharmaceutical Co. Ltd.
Form 483 issued October 13, 2017 · Chifeng, China
- Inspection
- Oct 11 – Oct 13, 2017
- Investigator
- Latorie S. Jones
- Observations
- 9
- Pages
- 6
- FEI number
- 1000390117
In short: On October 13, 2017, FDA issued a Form 483 with 9 observations to Chifeng Pharmaceutical Co. Ltd. in Chifeng, Inner Mongolia (FEI 1000390117) after an inspection that ran Oct 11 – Oct 13, 2017. The investigator was Latorie S. Jones. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Facilities & equipment and production account for 7 of 9 observations.
Most cited: 21 CFR 211.68 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
In process products are not…
- 02
Material management is not…
- 03
Failure to document…
- 04
Alarms not reviewed for…
This inspection in context
Latorie S. Jones
21 documents · 2015–2024
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Arkansas.
The firmChifeng 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 Chifeng Pharmaceutical Co. Ltd.?
FDA listed 9 observations on this Form 483, mostly about facilities & equipment, production and materials. 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 Chifeng Pharmaceutical Co. Ltd.?
Latorie S. Jones is named on this Form 483, for the inspection of Oct 11 – Oct 13, 2017. Each investigator has a profile showing what they cite most.
When was Chifeng Pharmaceutical Co. Ltd. inspected by FDA?
The inspection ran Oct 11 – Oct 13, 2017, and the Form 483 is dated October 13, 2017.
How do I get the full Form 483 for Chifeng 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.