FEI 3007200605
FDA inspection history in Mesa, Arizona, 2014 to 2015
- 2
- Form 483s
- 1
- Response
Every document, by year
- Response
- Form 483
2014: two Form 483s; 2015: one 483 response.
The story so far
Built from the dates and citations on the documents themselves.
- 2014–15Two Form 483s and one 483 response, at Mesa, Arizona.
- 2014The longest 483 on file: 8 observations over 5 pages at Mesa, Arizona.
Cited most
Across all site observations on file
- 21 CFR 211.113(b)Control of microbiological contamination2
- 21 CFR 211.166Stability testing2
- 21 CFR 211.28Personnel responsibilities2
- 21 CFR 211.167(a)Special testing requirements1
- 21 CFR 211.192Production record review1
The complete site file.
All 3 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
Mesa, Arizona
Two Form 483s and one 483 response · 2014 to 2015 · 11 observations
Latest: Response, Mar 30, 2015 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2015-03-30 | Response 483 response | Mesa, Arizona | — | $199 |
| 2014-12-02 | 483 Form 483 | Mesa, Arizona | 3 | $99 |
| 2014-01-09 | 483 Form 483 | Mesa, Arizona | 8 | $99 |
Investigators on these documents
Joey V. Quitania (1)Paul A. Bonneau (1)Timothy T. Kapaala (1)
FEI number 3007200605 · most recent document Mar 30, 2015
About FEI 3007200605
How many FDA Form 483s has FEI 3007200605 received?
FDA Intel has 2 Form 483s on file for FEI 3007200605; the most recent is dated Dec 2, 2014.
When was FEI 3007200605 last inspected by FDA?
The most recent FDA inspection document on file for FEI 3007200605 is a Form 483 dated Dec 2, 2014, for the site in Mesa, Arizona.
What did FDA cite at FEI 3007200605?
The regulations cited most in the observations on file for FEI 3007200605 are 21 CFR 211.113(b) (Control of microbiological contamination), 2 times; 21 CFR 211.166 (Stability testing), 2 times; 21 CFR 211.28 (Personnel responsibilities), 2 times.