FEI 3009641885
FDA inspection history in Southfield, Michigan, 2013 to 2014
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2013: one Form 483; 2014: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2013–14One Form 483 and one warning letter, at Southfield, Michigan.
Cited most
Across all site observations on file
- 21 CFR 211.100(a)Written procedures; deviations1
- 21 CFR 211.111Time limitations on production1
- 21 CFR 211.113(b)Control of microbiological contamination1
- 21 CFR 211.160(a)General requirements1
- 21 CFR 211.165(a)Testing and release for distribution1
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
Southfield, Michigan
One warning letter and one Form 483 · 2013 to 2014 · 13 observations
Latest: Warning letter, Sep 24, 2014 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2014-09-24 | Warning letter Warning letter | Southfield, Michigan | — | $99 |
| 2013-07-19 | 483 Form 483 | Southfield, Michigan | 13 | $99 |
Investigators on these documents
FEI number 3009641885 · most recent document Sep 24, 2014
About FEI 3009641885
How many FDA Form 483s has FEI 3009641885 received?
FDA Intel has 1 Form 483 on file for FEI 3009641885; the most recent is dated Jul 19, 2013.
When was FEI 3009641885 last inspected by FDA?
The most recent FDA inspection document on file for FEI 3009641885 is a Form 483 dated Jul 19, 2013, for the site in Southfield, Michigan.
What did FDA cite at FEI 3009641885?
The regulations cited most in the observations on file for FEI 3009641885 are 21 CFR 211.100(a) (Written procedures; deviations), 1 time; 21 CFR 211.111 (Time limitations on production), 1 time; 21 CFR 211.113(b) (Control of microbiological contamination), 1 time.
Has FEI 3009641885 received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for FEI 3009641885; the most recent is dated Sep 24, 2014.