Unico Holdings, Inc.
Form 483 issued February 14, 2006 · Lake Worth, Florida
- Inspection
- Feb 6 – Feb 14, 2006
- Investigator
- Sean T. Creighton
- Observations
- 19
- Pages
- 12
- FEI number
- 1000140268
In short: On February 14, 2006, FDA issued a Form 483 with 19 observations to Unico Holdings, Inc. in Lake Worth, Florida (FEI 1000140268) after an inspection that ran Feb 6 – Feb 14, 2006. The investigator was Sean T. Creighton. Most observations concern food CGMP / preventive controls and facilities & equipment; the most-cited regulation is 21 CFR 110.80 (processes and controls).
At a glance
12 of 19 observations on this 483 concern food cgmp / preventive controls.
Most cited: 21 CFR 110.80 (5×) · 110.20 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Appropriate training in food handling techniques and food protection principles has not been provided to food…
- 02
Failure to perform mechanical manufacturing steps so as to protect…
- 03
All reasonable precautions are not taken to ensure that production procedures do not contribute contamination…
- 04
Failure to perform filling, assembling, and packaging in a manner that protects food…
This inspection in context
Sean T. Creighton
9 documents · 2006–2020
Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in California.
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 19 observations on this Form 483, mostly about food CGMP / preventive controls, facilities & equipment and production. 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.?
Sean T. Creighton is named on this Form 483, for the inspection of Feb 6 – Feb 14, 2006. Each investigator has a profile showing what they cite most.
When was Unico Holdings, Inc. inspected by FDA?
The inspection ran Feb 6 – Feb 14, 2006, and the Form 483 is dated February 14, 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.