Cramer Products Inc
FDA inspection history in Gardner, Kansas, 2015 to 2017
- 2
- Form 483s
Every document, by year
- Form 483
2015: one Form 483; 2017: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015–17Two Form 483s, at Gardner, Kansas.
- 2015The longest 483 on file: 16 observations over 11 pages at Gardner, Kansas.
Cited most
Across all Cramer Products observations on file
- 21 CFR 211.160General requirements2
- 21 CFR 211.165Testing and release for distribution2
- 21 CFR 211.166Stability testing2
- 21 CFR 211.194(a)(8)Laboratory records2
- 21 CFR 211.68(a)Automatic, mechanical, and electronic equipment2
The complete Cramer Products 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
Gardner, Kansas
Two Form 483s · 2015 to 2017 · 29 observations
Latest: Form 483, Apr 14, 2017 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2017-04-14 | 483 Form 483 | Gardner, Kansas | 13 | $99 |
| 2015-10-26 | 483 Form 483 | Gardner, Kansas | 16 | $99 |
Investigators on these documents
Ashley A. Mutawakkil (1)Brett R. Havranek (1)Rita K. Kabaso (1)Veronica Fuentes (1)
FEI number 1910082 · most recent document Apr 14, 2017
About Cramer Products Inc
How many FDA Form 483s has Cramer Products Inc received?
FDA Intel has 2 Form 483s on file for Cramer Products Inc; the most recent is dated Apr 14, 2017.
When was Cramer Products Inc last inspected by FDA?
The most recent FDA inspection document on file for Cramer Products Inc is a Form 483 dated Apr 14, 2017, for the site in Gardner, Kansas.
What did FDA cite at Cramer Products Inc?
The regulations cited most in the observations on file for Cramer Products Inc are 21 CFR 211.160 (General requirements), 2 times; 21 CFR 211.165 (Testing and release for distribution), 2 times; 21 CFR 211.166 (Stability testing), 2 times.