Cramer Products Inc
Form 483 issued October 26, 2015 · Gardner, Kansas
- Inspection
- Oct 14 – Oct 26, 2015
- Investigators
- Ashley A. Mutawakkil· Rita K. Kabaso
- Observations
- 16
- Pages
- 11
- FEI number
- 1910082
In short: On October 26, 2015, FDA issued a Form 483 with 16 observations to Cramer Products Inc in Gardner, Kansas (FEI 1910082) after an inspection that ran Oct 14 – Oct 26, 2015. The investigators were Ashley A. Mutawakkil and Rita K. Kabaso. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 820.198 (complaint files).
At a glance
Observations span 4 systems, led by laboratory controls.
Most cited: 21 CFR 820.198 (2×) · 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit are…
- 02
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of…
- 03
The written MDR procedure does not include an internal system which provides for a standardized review…
- 04
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
This inspection in context
Ashley A. Mutawakkil
4 documents · 2015–2022
Cites 211.160 (general requirements) 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 820.198
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Cramer Products Inc?
FDA listed 16 observations on this Form 483, mostly about laboratory controls, quality system and cAPA. The most-cited regulation is 21 CFR 820.198 (complaint files). The opening words of each observation are shown on this page.
Who inspected Cramer Products Inc?
Ashley A. Mutawakkil and Rita K. Kabaso are named on this Form 483, for the inspection of Oct 14 – Oct 26, 2015. Each investigator has a profile showing what they cite most.
When was Cramer Products Inc inspected by FDA?
The inspection ran Oct 14 – Oct 26, 2015, and the Form 483 is dated October 26, 2015.
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.