Kang Zhang, M.D., Ph.D
Form 483 issued August 1, 2016 · La Jolla, California
- Inspection
- Jul 14 – Aug 1, 2016
- Investigator
- Natalie J. Ayoub
- Observations
- 7
- Pages
- 6
- FEI number
- 3012242764
In short: On August 1, 2016, FDA issued a Form 483 with 7 observations to Kang Zhang, M.D., Ph.D in La Jolla, California (FEI 3012242764) after an inspection that ran Jul 14 – Aug 1, 2016. The investigator was Natalie J. Ayoub. Most observations concern clinical (BIMO); the most-cited regulation is 21 CFR 312.56 (review of ongoing investigations).
At a glance
7 of 7 observations on this 483 concern clinical (bimo).
What FDA observed
Preview: the opening words of each observation- 01
Failure to monitor the progress of an investigation…
- 02
Failure to submit to FDA an annual report of…
- 03
Failure to assure that an IRB was responsible for the initial and continuing review and approval…
- 04
An investigation was not conducted in accordance…
This inspection in context
Natalie J. Ayoub
3 documents · 2016–2017
Cites 312.56(a) (review of ongoing investigations) more than any other section. Most of their documents are for sites in California.
The firmKang Zhang, M.D., Ph.D history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 312.56(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Kang Zhang, M.D., Ph.D?
FDA listed 7 observations on this Form 483, mostly about clinical (BIMO). The most-cited regulation is 21 CFR 312.56 (review of ongoing investigations). The opening words of each observation are shown on this page.
Who inspected Kang Zhang, M.D., Ph.D?
Natalie J. Ayoub is named on this Form 483, for the inspection of Jul 14 – Aug 1, 2016. Each investigator has a profile showing what they cite most.
When was Kang Zhang, M.D., Ph.D inspected by FDA?
The inspection ran Jul 14 – Aug 1, 2016, and the Form 483 is dated August 1, 2016.
How do I get the full Form 483 for Kang Zhang, M.D., Ph.D?
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.