Jianerkang Medical Co., Ltd.
Form 483 issued November 1, 2019 · Changzhou, China
- Inspection
- Oct 28 – Nov 1, 2019
- Investigator
- Joows Lorimer Yustan-Toves
- Observations
- 2
- Pages
- 2
- FEI number
- 3006403682
In short: On November 1, 2019, FDA issued a Form 483 with 2 observations to Jianerkang Medical Co., Ltd. in Changzhou, China (FEI 3006403682) after an inspection that ran Oct 28 – Nov 1, 2019. The investigator was Joows Lorimer Yustan-Toves. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
2 of 2 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.160 (1×) · 211.166 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans and test…
- 02
The written stability program for drug products does not include meaningful…
This inspection in context
Joows Lorimer Yustan-Toves
1 document · 2019
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in China.
The firmJianerkang Medical Co., Ltd. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Jianerkang Medical Co., Ltd.?
FDA listed 2 observations on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Jianerkang Medical Co., Ltd.?
Joows Lorimer Yustan-Toves is named on this Form 483, for the inspection of Oct 28 – Nov 1, 2019. Each investigator has a profile showing what they cite most.
When was Jianerkang Medical Co., Ltd. inspected by FDA?
The inspection ran Oct 28 – Nov 1, 2019, and the Form 483 is dated November 1, 2019.
How do I get the full Form 483 for Jianerkang Medical 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.