Form 483 · FEI 2434377
Form 483 issued July 8, 2016 · New York, New York
- Inspection
- Jun 28 – Jul 8, 2016
- Investigators
- Alice S. Tsuo· Mindy M. Chou
- Observations
- 4
- Pages
- 2
- FEI number
- 2434377
In short: On July 8, 2016, FDA issued a Form 483 with 4 observations to an FDA-inspected site in New York, New York (FEI 2434377) after an inspection that ran Jun 28 – Jul 8, 2016. The investigators were Alice S. Tsuo and Mindy M. Chou. Most observations concern facilities & equipment and production.
At a glance
Facilities & equipment and production account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
Inadequate aseptic techniques demonstrated by the operators who prepare and…
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Alice S. Tsuo
1 document · 2016
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in New York.
The firmSite history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at an FDA-inspected site?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. The opening words of each observation are shown on this page.
Who inspected an FDA-inspected site?
Alice S. Tsuo and Mindy M. Chou are named on this Form 483, for the inspection of Jun 28 – Jul 8, 2016. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Jun 28 – Jul 8, 2016, and the Form 483 is dated July 8, 2016.
How do I get the full Form 483 for an FDA-inspected site?
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.