Unico Holdings, Inc.
Form 483 issued January 27, 2009 · Lake Worth, Oregon
- Inspection
- Jan 14 – Jan 27, 2009
- Investigators
- Ethan P. Stegman· Mary F. Bodick
- Observations
- 5
- Pages
- 2
- FEI number
- 1000140268
In short: On January 27, 2009, FDA issued a Form 483 with 5 observations to Unico Holdings, Inc. in Lake Worth, Oregon (FEI 1000140268) after an inspection that ran Jan 14 – Jan 27, 2009. The investigators were Ethan P. Stegman and Mary F. Bodick. Most observations concern food CGMP / preventive controls; the most-cited regulation is 21 CFR 110.80 (processes and controls).
At a glance
4 of 5 observations on this 483 concern food cgmp / preventive controls.
Most cited: 21 CFR 110.80 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
An adverse event report for a nonprescription drug was not submitted to the Secretary of HHS…
- 02
Failure to manufacture foods under conditions and controls necessary to minimize the potential…
- 03
Failure to perform filling and packaging in a manner that protects…
- 04
Failure to take apart equipment as necessary…
This inspection in context
Ethan P. Stegman
1 document · 2009
Cites 110.80 (processes and controls) more than any other section. Most of their documents are for sites in Oregon.
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 5 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.?
Ethan P. Stegman and Mary F. Bodick are named on this Form 483, for the inspection of Jan 14 – Jan 27, 2009. Each investigator has a profile showing what they cite most.
When was Unico Holdings, Inc. inspected by FDA?
The inspection ran Jan 14 – Jan 27, 2009, and the Form 483 is dated January 27, 2009.
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.