Foundation Care LLC
FDA inspection history in Earth City, Missouri, 2007 to 2014
- 2
- Responses
- 2
- Form 483s
- 2
- EIRs
Every document, by year
- Response
- Form 483
- EIR
2007: one inspection report and one Form 483; 2013: one 483 response, one Form 483 and one inspection report; 2014: one 483 response.
The story so far
Built from the dates and citations on the documents themselves.
- 2007One inspection report and one Form 483, at Earth City, Missouri.
- 2013–14Two 483 responses, one Form 483 and one inspection report, at Earth City, Missouri.
- 2013The longest 483 on file: 7 observations over 6 pages at Earth City, Missouri.
Cited most
Across all Foundation Care observations on file
- 21 CFR 211.113(b)Control of microbiological contamination1
- 21 CFR 211.160(b)General requirements1
- 21 CFR 211.165(b)Testing and release for distribution1
- 21 CFR 211.184(a)Component, drug product container, closure, and labeling records1
- 21 CFR 211.28(a)Personnel responsibilities1
The complete Foundation Care file.
All 6 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Earth City, Missouri
Two 483 responses, two Form 483s and two inspection reports · 2007 to 2014 · 7 observations
Latest: Response, Feb 26, 2014 →
Documents
6 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2014-02-26 | Response 483 response | Earth City, Missouri | — | $199 |
| 2013-04-09 | Response 483 response | Earth City, Missouri | — | $199 |
| 2013-03-19 | 483 Form 483 | Earth City, Missouri | 7 | $99 |
| 2013-03-19 | EIR EIR | Earth City, Missouri | — | $550 |
| 2007-08-27 | EIR EIR | Earth City, Missouri | — | $550 |
| 2007-08-27 | 483 Form 483 | Earth City, Missouri | — | $99 |
Investigators on these documents
Shirley J. Berryman (3)Anthony R. Bucks (3)Erika V. Butler (2)Michele Perry Williams (2)Michelle Perry Williams (1)Shirley J. Byman (1)Shirley J. Man (1)
FEI number 3005364771 · most recent document Feb 26, 2014
About Foundation Care LLC
How many FDA Form 483s has Foundation Care LLC received?
FDA Intel has 2 Form 483s on file for Foundation Care LLC; the most recent is dated Mar 19, 2013.
When was Foundation Care LLC last inspected by FDA?
The most recent FDA inspection document on file for Foundation Care LLC is a Form 483 dated Mar 19, 2013, for the site in Earth City, Missouri.
What did FDA cite at Foundation Care LLC?
The regulations cited most in the observations on file for Foundation Care LLC are 21 CFR 211.113(b) (Control of microbiological contamination), 1 time; 21 CFR 211.160(b) (General requirements), 1 time; 21 CFR 211.165(b) (Testing and release for distribution), 1 time.