Cincinnati Sub-Zero Products LLC
Form 483 issued August 30, 2018 · Cincinnati, Ohio
- Inspection
- Aug 8 – Aug 30, 2018
- Investigators
- Christina L. Bigham· Teresa K. Kastner
- Observations
- 1
- Pages
- 9
- FEI number
- 1516825
In short: On August 30, 2018, FDA issued a Form 483 with 1 observation to Cincinnati Sub-Zero Products LLC in Cincinnati, Ohio (FEI 1516825) after an inspection that ran Aug 8 – Aug 30, 2018. 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
Procedures for design validation have…
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 1 observation 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 Aug 8 – Aug 30, 2018. Each investigator has a profile showing what they cite most.
When was Cincinnati Sub-Zero Products LLC inspected by FDA?
The inspection ran Aug 8 – Aug 30, 2018, and the Form 483 is dated August 30, 2018.
How do I get the full Form 483 for Cincinnati Sub-Zero Products LLC?
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.