FEI 3008778967
FDA inspection history across 2 sites, 2011
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2011: one warning letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2011One warning letter and one Form 483, at Oskaloosa, Iowa and Fremont, Iowa.
Cited most
Across all site observations on file
- 21 CFR 118.4Salmonella Enteritidis (SE) prevention measures5
- 21 CFR 118.10(a)(3)(iv)Recordkeeping requirements for the Salmonella Enteritidis (SE) prevention plan2
- 21 CFR 118.5(a)Environmental testing for Salmonella Enteritidis (SE)1
- 21 CFR 118.7(a)Sampling methodology for Salmonella Enteritidis (SE)1
- 21 CFR 118.8(a)Testing methodology for Salmonella Enteritidis (SE)1
The complete site 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
Oskaloosa, Iowa
One warning letter · 2011
Latest: Warning letter, Oct 21, 2011 →Fremont, Iowa
One Form 483 · 2011 · 10 observations
Latest: Form 483, Jun 29, 2011 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2011-10-21 | Warning letter Warning letter | Oskaloosa, Iowa | — | $99 |
| 2011-06-29 | 483 Form 483 | Fremont, Iowa | 10 | $99 |
Investigators on these documents
FEI number 3008778967 · most recent document Oct 21, 2011
About FEI 3008778967
How many FDA Form 483s has FEI 3008778967 received?
FDA Intel has 1 Form 483 on file for FEI 3008778967; the most recent is dated Jun 29, 2011.
When was FEI 3008778967 last inspected by FDA?
The most recent FDA inspection document on file for FEI 3008778967 is a Form 483 dated Jun 29, 2011, for the site in Fremont, Iowa.
What did FDA cite at FEI 3008778967?
The regulations cited most in the observations on file for FEI 3008778967 are 21 CFR 118.4 (Salmonella Enteritidis (SE) prevention measures), 5 times; 21 CFR 118.10(a)(3)(iv) (Recordkeeping requirements for the Salmonella Enteritidis (SE) prevention plan), 2 times; 21 CFR 118.5(a) (Environmental testing for Salmonella Enteritidis (SE)), 1 time.
Has FEI 3008778967 received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for FEI 3008778967; the most recent is dated Oct 21, 2011.