Unico Holdings, Inc.
Form 483 issued July 22, 2005 · Lake Worth, Florida
- Inspection
- Jul 19 – Jul 22, 2005
- Investigator
- Ana Del P. Cintron
- Observations
- 5
- Pages
- 3
- FEI number
- 1000140268
In short: On July 22, 2005, FDA issued a Form 483 with 5 observations to Unico Holdings, Inc. in Lake Worth, Florida (FEI 1000140268) after an inspection that ran Jul 19 – Jul 22, 2005. The investigator was Ana Del P. Cintron. Most observations concern materials and laboratory controls.
At a glance
3 of 5 observations on this 483 concern materials.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Results of stability testing are not used…
- 02
Drug product production and control records, are not reviewed by the quality control unit to determine…
- 03
Written production and process control procedures are not documented at…
- 04
Written procedures are lacking which describe in sufficient detail…
This inspection in context
Ana Del P. Cintron
1 document · 2005
Cites 211.100 (written procedures; deviations) 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 211.166
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 materials, laboratory controls and production. The opening words of each observation are shown on this page.
Who inspected Unico Holdings, Inc.?
Ana Del P. Cintron is named on this Form 483, for the inspection of Jul 19 – Jul 22, 2005. Each investigator has a profile showing what they cite most.
When was Unico Holdings, Inc. inspected by FDA?
The inspection ran Jul 19 – Jul 22, 2005, and the Form 483 is dated July 22, 2005.
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.