Dexta Corporation
FDA inspection history in Napa, California, 2014 to 2015
- 1
- Form 483
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2014: one warning letter; 2015: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2014–15One warning letter and one Form 483, at Napa, California.
Cited most
Across all Dexta observations on file
- 21 CFR 820.198(a)Complaint files1
- 21 CFR 820.25(b)Personnel1
- 21 CFR 820.50Purchasing controls1
- 21 CFR 820.70(c)Production and process controls1
- 21 CFR 820.75(a)Process validation1
The complete Dexta file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Napa, California
One Form 483 and one warning letter · 2014 to 2015 · 7 observations
Latest: Form 483, Feb 3, 2015 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2015-02-03 | 483 Form 483 | Napa, California | 7 | $99 |
| 2014-06-25 | Warning letter Warning letter | Napa, California | — | $99 |
Investigators on these documents
FEI number 2916273 · most recent document Feb 3, 2015
About Dexta Corporation
How many FDA Form 483s has Dexta Corporation received?
FDA Intel has 1 Form 483 on file for Dexta Corporation; the most recent is dated Feb 3, 2015.
When was Dexta Corporation last inspected by FDA?
The most recent FDA inspection document on file for Dexta Corporation is a Form 483 dated Feb 3, 2015, for the site in Napa, California.
What did FDA cite at Dexta Corporation?
The regulations cited most in the observations on file for Dexta Corporation are 21 CFR 820.198(a) (Complaint files), 1 time; 21 CFR 820.25(b) (Personnel), 1 time; 21 CFR 820.50 (Purchasing controls), 1 time.
Has Dexta Corporation received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Dexta Corporation; the most recent is dated Jun 25, 2014.