Custom Foam Systems Ltd
Form 483 issued November 19, 2015 · Kitchener, Canada
- Inspection
- Nov 16 – Nov 19, 2015
- Investigator
- That Q. Dang
- Observations
- 4
- Pages
- 3
- FEI number
- 3002668219
In short: On November 19, 2015, FDA issued a Form 483 with 4 observations to Custom Foam Systems Ltd in Kitchener, ON NEK (FEI 3002668219) after an inspection that ran Nov 16 – Nov 19, 2015. The investigator was That Q. Dang. Most observations concern cAPA and management controls.
At a glance
3 of 4 observations on this 483 concern capa.
What FDA observed
Preview: the opening words of each observation- 01
Personnel training is not…
- 02
Procedures have not been adequately established to control product that does not…
- 03
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
- 04
Procedures for corrective and preventive action have…
This inspection in context
That Q. Dang
4 documents · 2015–2016
Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in Canada.
The firmCustom Foam Systems Ltd history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.25(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Custom Foam Systems Ltd?
FDA listed 4 observations on this Form 483, mostly about cAPA and management controls. The opening words of each observation are shown on this page.
Who inspected Custom Foam Systems Ltd?
That Q. Dang is named on this Form 483, for the inspection of Nov 16 – Nov 19, 2015. Each investigator has a profile showing what they cite most.
When was Custom Foam Systems Ltd inspected by FDA?
The inspection ran Nov 16 – Nov 19, 2015, and the Form 483 is dated November 19, 2015.
How do I get the full Form 483 for Custom Foam Systems Ltd?
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.