Unico Holdings, Inc.
Form 483 issued July 13, 2006 · Lake Worth, Florida
- Inspection
- Jul 10 – Jul 13, 2006
- Investigator
- Mary F. Bodick
- Observations
- 4
- Pages
- 2
- FEI number
- 1000140268
In short: On July 13, 2006, FDA issued a Form 483 with 4 observations to Unico Holdings, Inc. in Lake Worth, Florida (FEI 1000140268) after an inspection that ran Jul 10 – Jul 13, 2006. The investigator was Mary F. Bodick. Most observations concern food CGMP / preventive controls.
At a glance
4 of 4 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 perform packaging in a manner that protects…
- 02
Responsibility for assuring compliance with current good manufacturing practices relating to personnel has not been assigned…
- 03
Instruments used for measuring conditions that control or prevent the growth of undesirable microorganisms…
- 04
Lack of backflow protection from piping systems…
This inspection in context
Mary F. Bodick
3 documents · 2006–2009
Cites 110.80 (processes and controls) 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 110.80
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 opening words of each observation are shown on this page.
Who inspected Unico Holdings, Inc.?
Mary F. Bodick is named on this Form 483, for the inspection of Jul 10 – Jul 13, 2006. Each investigator has a profile showing what they cite most.
When was Unico Holdings, Inc. inspected by FDA?
The inspection ran Jul 10 – Jul 13, 2006, and the Form 483 is dated July 13, 2006.
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.