Setton International Foods, Inc.
Form 483 issued April 8, 2009 · Commack, New York
- Inspection
- Mar 31 – Apr 8, 2009
- Investigators
- Frank Verni'· Jane Chen· Matthew R. Palo
- Observations
- 3
- Pages
- 3
- FEI number
- 2433583
In short: On April 8, 2009, FDA issued a Form 483 with 3 observations to Setton International Foods, Inc. in Commack, New York (FEI 2433583) after an inspection that ran Mar 31 – Apr 8, 2009. The investigators were Frank Verni', Jane Chen, Matthew R. Palo and Sarah A. Wangseng. Most observations concern food CGMP / preventive controls; the most-cited regulation is 21 CFR 110.10 (personnel).
At a glance
3 of 3 observations on this 483 concern food cgmp / preventive controls.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to conduct cleaning and sanitizing operations for utensils and equipment in a mannenhat protects against…
- 03
Employees did not wash hands thoroughly in an adequate hand-washing facility at any time their hands…
- 06
Failure to provide safety-type lighting fixtures suspended over exposed food…
This inspection in context
Frank Verni'
4 documents · 2009
Cites 110.35 (sanitary operations) more than any other section. Most of their documents are for sites in New York.
The firmSetton International Foods, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 110.35
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Setton International Foods, Inc.?
FDA listed 3 observations on this Form 483, mostly about food CGMP / preventive controls. The most-cited regulation is 21 CFR 110.10 (personnel). The opening words of each observation are shown on this page.
Who inspected Setton International Foods, Inc.?
Frank Verni', Jane Chen, Matthew R. Palo and Sarah A. Wangseng are named on this Form 483, for the inspection of Mar 31 – Apr 8, 2009. Each investigator has a profile showing what they cite most.
When was Setton International Foods, Inc. inspected by FDA?
The inspection ran Mar 31 – Apr 8, 2009, and the Form 483 is dated April 8, 2009.
How do I get the full Form 483 for Setton International Foods, Inc.?
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.