Unico Holdings, Inc.
Form 483 issued August 2, 2007 · Lake Worth, Florida
- Inspection
- Jul 18 – Aug 2, 2007
- Investigator
- Albertfiel A. Salvador
- Observations
- 4
- Pages
- 3
- FEI number
- 1000140268
In short: On August 2, 2007, FDA issued a Form 483 with 4 observations to Unico Holdings, Inc. in Lake Worth, Florida (FEI 1000140268) after an inspection that ran Jul 18 – Aug 2, 2007. The investigator was Albertfiel A. Salvador. Most observations concern food CGMP / preventive controls; the most-cited regulation is 21 CFR 110.80 (processes and controls).
At a glance
4 of 4 observations on this 483 concern food cgmp / preventive controls.
Most cited: 21 CFR 110.40 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
All reasonable precautions are not taken to ensure that production procedures do not contribute…
- 02
Failure to maintain equipment, containers and utensils used to convey food in a manner…
- 03
Failure to operate fans and other air-blowing equipment in a manner that minimizes the…
- 04
Failure to store finished food under conditions that would protect against deterioration of the…
This inspection in context
Albertfiel A. Salvador
1 document · 2007
Cites 110.40 (equipment and utensils) more than any other section. Most of their documents are for sites in Florida.
The firmUnico Holdings, Inc. history
All 7 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 110.40
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Unico Holdings, Inc.?
FDA listed 4 observations on this Form 483, mostly about food CGMP / preventive controls. The most-cited regulation is 21 CFR 110.80 (processes and controls). The opening words of each observation are shown on this page.
Who inspected Unico Holdings, Inc.?
Albertfiel A. Salvador is named on this Form 483, for the inspection of Jul 18 – Aug 2, 2007. Each investigator has a profile showing what they cite most.
When was Unico Holdings, Inc. inspected by FDA?
The inspection ran Jul 18 – Aug 2, 2007, and the Form 483 is dated August 2, 2007.
How do I get the full Form 483 for Unico Holdings, 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.