Joinri'Laboratories Co., Ltd.
Form 483 issued September 20, 2013 · Beijing, China
- Inspection
- Sep 16 – Sep 20, 2013
- Investigators
- Francis J. Eng· Niras B. Mehta· Zhou Chen
- Observations
- 4
- Pages
- 1
In short: On September 20, 2013, FDA issued a Form 483 with 4 observations to Joinri'Laboratories Co., Ltd. in Beijing, China after an inspection that ran Sep 16 – Sep 20, 2013. The investigators were Francis J. Eng, Niras B. Mehta and Zhou Chen. Most observations concern gLP; the most-cited regulation is 21 CFR 58.33 (study director).
At a glance
4 of 4 observations on this 483 concern glp.
Most cited: 21 CFR 58.33 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The QAU failed to review the final study report to assure that the reported results accurately…
- 02
The study director failed to assure that the protocol, including any change…
- 03
The study director failed to assure that all raw data, documentation, protocols, specimens, and final reports…
- 04
The study director failed to assure that all experimental data were…
This inspection in context
Francis J. Eng
1 document · 2013
Cites 58.33 (study director) more than any other section. Most of their documents are for sites in China.
The firmJoinri'Laboratories Co., Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 58.33
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Joinri'Laboratories Co., Ltd.?
FDA listed 4 observations on this Form 483, mostly about gLP. The most-cited regulation is 21 CFR 58.33 (study director). The opening words of each observation are shown on this page.
Who inspected Joinri'Laboratories Co., Ltd.?
Francis J. Eng, Niras B. Mehta and Zhou Chen are named on this Form 483, for the inspection of Sep 16 – Sep 20, 2013. Each investigator has a profile showing what they cite most.
When was Joinri'Laboratories Co., Ltd. inspected by FDA?
The inspection ran Sep 16 – Sep 20, 2013, and the Form 483 is dated September 20, 2013.
How do I get the full Form 483 for Joinri'Laboratories 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.