Unico Holdings, Inc.
FDA inspection history across 2 sites, 2002 to 2009
- 6
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2002: one warning letter; 2005: one Form 483; 2006: two Form 483s; 2007: one Form 483; 2008: one Form 483; 2009: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2002One warning letter, at Lake Worth, Florida.
- 2005–09Six Form 483s, at Lake Worth, Florida and Lake Worth, Oregon.
- 2006The longest 483 on file: 19 observations over 12 pages at Lake Worth, Florida.
Cited most
Across all Unico Holdings observations on file
- 21 CFR 110.80Processes and controls9
- 21 CFR 110.40Equipment and utensils4
- 21 CFR 110.20Plant and grounds3
- 21 CFR 110.37Sanitary facilities and controls3
- 21 CFR 110.10Personnel2
The complete Unico Holdings file.
All 7 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Lake Worth, Florida
Five Form 483s and one warning letter · 2002 to 2008 · 35 observations
Latest: Form 483, Feb 11, 2008 →Lake Worth, Oregon
One Form 483 · 2009 · 5 observations
Latest: Form 483, Jan 27, 2009 →
Documents
7 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2009-01-27 | 483 Form 483 | Lake Worth, Oregon | 5 | $99 |
| 2008-02-11 | 483 Form 483 | Lake Worth, Florida | 3 | $99 |
| 2007-08-02 | 483 Form 483 | Lake Worth, Florida | 4 | $99 |
| 2006-07-13 | 483 Form 483 | Lake Worth, Florida | 4 | $99 |
| 2006-02-14 | 483 Form 483 | Lake Worth, Florida | 19 | $99 |
| 2005-07-22 | 483 Form 483 | Lake Worth, Florida | 5 | $99 |
| 2002-10-18 | Warning letter Warning letter | Lake Worth, Florida | — | $99 |
Investigators on these documents
Mary F. Bodick (2)Albertfiel A. Salvador (1)Ana Del P. Cintron (1)Ethan P. Stegman (1)German Rivera (1)Sean T. Creighton (1)
FEI number 1000140268 · most recent document Jan 27, 2009
About Unico Holdings, Inc.
How many FDA Form 483s has Unico Holdings, Inc. received?
FDA Intel has 6 Form 483s on file for Unico Holdings, Inc.; the most recent is dated Jan 27, 2009.
When was Unico Holdings, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Unico Holdings, Inc. is a Form 483 dated Jan 27, 2009, for the site in Lake Worth, Oregon.
What did FDA cite at Unico Holdings, Inc.?
The regulations cited most in the observations on file for Unico Holdings, Inc. are 21 CFR 110.80 (Processes and controls), 9 times; 21 CFR 110.40 (Equipment and utensils), 4 times; 21 CFR 110.20 (Plant and grounds), 3 times.
Has Unico Holdings, Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Unico Holdings, Inc.; the most recent is dated Oct 18, 2002.