FEI 3010450840
FDA inspection history in South Lyon, Michigan, 2013 to 2015
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2013: one Form 483; 2015: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2013–15One Form 483 and one warning letter, at South Lyon, Michigan.
Cited most
Across all site observations on file
- 21 CFR 211.100(a)Written procedures; deviations1
- 21 CFR 211.113(b)Control of microbiological contamination1
- 21 CFR 211.160(b)General requirements1
- 21 CFR 211.165(a)Testing and release for distribution1
- 21 CFR 211.166(b)Stability testing1
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
South Lyon, Michigan
One warning letter and one Form 483 · 2013 to 2015 · 6 observations
Latest: Warning letter, Aug 31, 2015 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2015-08-31 | Warning letter Warning letter | South Lyon, Michigan | — | $99 |
| 2013-11-05 | 483 Form 483 | South Lyon, Michigan | 6 | $99 |
Investigators on these documents
FEI number 3010450840 · most recent document Aug 31, 2015
About FEI 3010450840
How many FDA Form 483s has FEI 3010450840 received?
FDA Intel has 1 Form 483 on file for FEI 3010450840; the most recent is dated Nov 5, 2013.
When was FEI 3010450840 last inspected by FDA?
The most recent FDA inspection document on file for FEI 3010450840 is a Form 483 dated Nov 5, 2013, for the site in South Lyon, Michigan.
What did FDA cite at FEI 3010450840?
The regulations cited most in the observations on file for FEI 3010450840 are 21 CFR 211.100(a) (Written procedures; deviations), 1 time; 21 CFR 211.113(b) (Control of microbiological contamination), 1 time; 21 CFR 211.160(b) (General requirements), 1 time.
Has FEI 3010450840 received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for FEI 3010450840; the most recent is dated Aug 31, 2015.