Cincinnati Sub-Zero Products LLC
Form 483 issued January 18, 2017 · Cincinnati, Ohio
- Inspection
- Nov 29, 2016 – Jan 18, 2017
- Investigators
- Christina L. Bigham· Teresa K. Kastner
- Observations
- 2
- Pages
- 8
- FEI number
- 1516825
In short: On January 18, 2017, FDA issued a Form 483 with 2 observations to Cincinnati Sub-Zero Products LLC in Cincinnati, Ohio (FEI 1516825) after an inspection that ran Nov 29, 2016 – Jan 18, 2017. The investigators were Christina L. Bigham and Teresa K. Kastner. Most observations concern design controls; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
1 of 1 observations on this 483 concern design controls.
Most cited: 21 CFR 820.30(g) (1×)
What FDA observed
Preview: the opening words of each observation- 01
The results of design validation, including identification of the design, method(s), the date and the individual(s)…
This inspection in context
Christina L. Bigham
11 documents · 2015–2026
Cites 820.30(c) (design controls) more than any other section. Most of their documents are for sites in Minnesota.
The firmCincinnati Sub-Zero Products LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.30(g)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Cincinnati Sub-Zero Products LLC?
FDA listed 2 observations on this Form 483, mostly about design controls. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected Cincinnati Sub-Zero Products LLC?
Christina L. Bigham and Teresa K. Kastner are named on this Form 483, for the inspection of Nov 29, 2016 – Jan 18, 2017. Each investigator has a profile showing what they cite most.
When was Cincinnati Sub-Zero Products LLC inspected by FDA?
The inspection ran Nov 29, 2016 – Jan 18, 2017, and the Form 483 is dated January 18, 2017.
How do I get the full Form 483 for Cincinnati Sub-Zero Products LLC?
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