Unico Holdings, Inc.
Form 483 issued February 11, 2008 · Lake Worth, Florida
- Inspection
- Jan 22 – Feb 11, 2008
- Investigator
- German Rivera
- Observations
- 3
- Pages
- 3
- FEI number
- 1000140268
In short: On February 11, 2008, FDA issued a Form 483 with 3 observations to Unico Holdings, Inc. in Lake Worth, Florida (FEI 1000140268) after an inspection that ran Jan 22 – Feb 11, 2008. The investigator was German Rivera. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.170 (reserve samples).
At a glance
Laboratory controls and facilities & equipment account for 2 of 3 observations.
Most cited: 21 CFR 211.170 (1×) · 211.68 (1×)
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
Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures…
- 03
Routine calibration, inspection, and checking of automatic and mechanical equipment is not performed according to a…
This inspection in context
German Rivera
2 documents · 2008–2013
Cites 211.113(b) (control of microbiological contamination) 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 211.170
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Unico Holdings, Inc.?
FDA listed 3 observations on this Form 483, mostly about laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.170 (reserve samples). The opening words of each observation are shown on this page.
Who inspected Unico Holdings, Inc.?
German Rivera is named on this Form 483, for the inspection of Jan 22 – Feb 11, 2008. Each investigator has a profile showing what they cite most.
When was Unico Holdings, Inc. inspected by FDA?
The inspection ran Jan 22 – Feb 11, 2008, and the Form 483 is dated February 11, 2008.
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.