Cramer Products Inc
Form 483 issued April 14, 2017 · Gardner, Kansas
- Inspection
- Mar 30 – Apr 14, 2017
- Investigators
- Brett R. Havranek· Veronica Fuentes
- Observations
- 13
- Pages
- 9
- FEI number
- 1910082
In short: On April 14, 2017, FDA issued a Form 483 with 13 observations to Cramer Products Inc in Gardner, Kansas (FEI 1910082) after an inspection that ran Mar 30 – Apr 14, 2017. The investigators were Brett R. Havranek and Veronica Fuentes. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Observations span 4 systems, led by laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 02
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 03
There are no written procedures for production and process controls designed to assure that the drug…
- 04
Laboratory records are deficient in that they do not include the signature of the second person…
This inspection in context
Brett R. Havranek
6 documents · 2015–2018
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Kansas.
The firmCramer Products Inc history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.68(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Cramer Products Inc?
FDA listed 13 observations on this Form 483, mostly about laboratory controls, facilities & equipment and production. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Cramer Products Inc?
Brett R. Havranek and Veronica Fuentes are named on this Form 483, for the inspection of Mar 30 – Apr 14, 2017. Each investigator has a profile showing what they cite most.
When was Cramer Products Inc inspected by FDA?
The inspection ran Mar 30 – Apr 14, 2017, and the Form 483 is dated April 14, 2017.
How do I get the full Form 483 for Cramer Products Inc?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.