Cascadia Manufacturing, Inc. d.b.a
Form 483 issued March 1, 2016 · Bellevue, Washington
- Inspection
- Jan 28 – Mar 1, 2016
- Investigator
- Christopher R. Czajka
- Observations
- 20
- Pages
- 10
- FEI number
- 3005105463
In short: On March 1, 2016, FDA issued a Form 483 with 20 observations to Cascadia Manufacturing, Inc. d.b.a in Bellevue, Washington (FEI 3005105463) after an inspection that ran Jan 28 – Mar 1, 2016. The investigator was Christopher R. Czajka. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Observations span 4 systems, led by laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures…
- 02
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity…
- 03
Each lot of a component that is liable to microbiological contamination that is objectionable in view…
- 04
Drug products do not bear an expiration date determined by appropriate stability data to assure they…
This inspection in context
Christopher R. Czajka
37 documents · 2015–2025
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in California.
The firmCascadia Manufacturing, Inc. d.b.a history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.160(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Cascadia Manufacturing, Inc. d.b.a?
FDA listed 20 observations on this Form 483, mostly about laboratory controls, facilities & equipment and materials. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Cascadia Manufacturing, Inc. d.b.a?
Christopher R. Czajka is named on this Form 483, for the inspection of Jan 28 – Mar 1, 2016. Each investigator has a profile showing what they cite most.
When was Cascadia Manufacturing, Inc. d.b.a inspected by FDA?
The inspection ran Jan 28 – Mar 1, 2016, and the Form 483 is dated March 1, 2016.
How do I get the full Form 483 for Cascadia Manufacturing, Inc. d.b.a?
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