Sage Products LLC
FDA inspection history across 2 sites, 2009 to 2019
- 2
- Form 483s
- 2
- Warning letters
- 1
- Close-out
Every document, by year
- Close-out
- Form 483
- Warning letter
2009: one warning letter; 2016: one Form 483; 2017: one warning letter; 2019: one close-out letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2009One warning letter, at Cary, Illinois.
- 2016–19Two Form 483s, one warning letter and one close-out letter, at Cary, Illinois and Kalamazoo, Michigan.
- 2016The longest 483 on file: 6 observations over 7 pages at Cary, Illinois.
Cited most
Across all Sage Products observations on file
- 21 CFR 211.160(a)General requirements1
- 21 CFR 211.165(e)Testing and release for distribution1
- 21 CFR 211.192Production record review1
- 21 CFR 211.67(a)Equipment cleaning and maintenance1
- 21 CFR 211.80(a)General requirements1
The complete Sage Products file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Cary, Illinois
Two Form 483s and two warning letters · 2009 to 2019 · 8 observations
Latest: Form 483, Jun 7, 2019 →Kalamazoo, Michigan
One close-out letter · 2019
Latest: Close-out, Sep 5, 2019 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-09-05 | Close-out Close-out letter | Kalamazoo, Michigan | — | $99 |
| 2019-06-07 | 483 Form 483 | Cary, Illinois | 2 | $99 |
| 2017-07-17 | Warning letter Warning letter | Cary, Illinois | — | $99 |
| 2016-09-01 | 483 Form 483 | Cary, Illinois | 6 | $99 |
| 2009-01-22 | Warning letter Warning letter | Cary, Illinois | — | $99 |
Investigators on these documents
Brittani N. Franklin (1)Christopher D. Leach (1)Debra I. Love (1)Emilie Kahn (1)Michael E. Maselli (1)Nicholas P. Diorio (1)That Q. Dang (1)Vioela J. Caze (1)
FEI number 1419181 · most recent document Sep 5, 2019
About Sage Products LLC
How many FDA Form 483s has Sage Products LLC received?
FDA Intel has 2 Form 483s on file for Sage Products LLC; the most recent is dated Jun 7, 2019.
When was Sage Products LLC last inspected by FDA?
The most recent FDA inspection document on file for Sage Products LLC is a Form 483 dated Jun 7, 2019, for the site in Cary, Illinois.
What did FDA cite at Sage Products LLC?
The regulations cited most in the observations on file for Sage Products LLC are 21 CFR 211.160(a) (General requirements), 1 time; 21 CFR 211.165(e) (Testing and release for distribution), 1 time; 21 CFR 211.192 (Production record review), 1 time.
Has Sage Products LLC received an FDA warning letter?
Yes. FDA Intel has 2 FDA warning letters on file for Sage Products LLC; the most recent is dated Jul 17, 2017.