Sugimoto, Danny, H., M.D
Form 483 issued May 20, 2015 · Chicago, Illinois
- Inspection
- May 5 – May 20, 2015
- Investigator
- Jennifer C. Johnson
- Observations
- 2
- Pages
- 3
- FEI number
- 3007207764
In short: On May 20, 2015, FDA issued a Form 483 with 2 observations to Sugimoto, Danny, H., M.D in Chicago, Illinois (FEI 3007207764) after an inspection that ran May 5 – May 20, 2015. The investigator was Jennifer C. Johnson. Most observations concern clinical (BIMO); the most-cited regulation is 21 CFR 312.62 (investigator recordkeeping and record retention).
At a glance
2 of 2 observations on this 483 concern clinical (bimo).
Most cited: 21 CFR 312.62(b) (1×) · 312.60 (1×)
What FDA observed
Preview: the opening words of each observation- 01
Failure to prepare or maintain adequate case histories with respect to observations and data…
- 02
An investigation was not conducted in accordance…
This inspection in context
Jennifer C. Johnson
2 documents · 2011–2015
Cites 110.10 (personnel) more than any other section. Most of their documents are for sites in Illinois.
The firmSugimoto, Danny, H., M.D history
The site's inspection history, in date order.
Similar 483sOther sites cited under 312.62(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sugimoto, Danny, H., M.D?
FDA listed 2 observations on this Form 483, mostly about clinical (BIMO). The most-cited regulation is 21 CFR 312.62 (investigator recordkeeping and record retention). The opening words of each observation are shown on this page.
Who inspected Sugimoto, Danny, H., M.D?
Jennifer C. Johnson is named on this Form 483, for the inspection of May 5 – May 20, 2015. Each investigator has a profile showing what they cite most.
When was Sugimoto, Danny, H., M.D inspected by FDA?
The inspection ran May 5 – May 20, 2015, and the Form 483 is dated May 20, 2015.
How do I get the full Form 483 for Sugimoto, Danny, H., M.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.