Tender Corporation d/b/a Adventure Ready Brands
Form 483 issued October 26, 2018 · Littleton, New Hampshire
- Inspection
- Oct 24 – Oct 26, 2018
- Investigator
- James W. Whitney
- Observations
- 2
- Pages
- 2
- FEI number
- 1250045
In short: On October 26, 2018, FDA issued a Form 483 with 2 observations to Tender Corporation d/b/a Adventure Ready Brands in Littleton, New Hampshire (FEI 1250045) after an inspection that ran Oct 24 – Oct 26, 2018. The investigator was James W. Whitney. Most observations concern cAPA; the most-cited regulation is 21 CFR 820.100 (corrective and preventive action).
At a glance
2 of 2 observations on this 483 concern capa.
Most cited: 21 CFR 820.100(a) (1×) · 820.198(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures for corrective and preventive action…
- 02
Complaint files are not…
This inspection in context
James W. Whitney
3 documents · 2017–2018
Cites 820.30(g) (design controls) more than any other section. Most of their documents are for sites in Belgium.
The firmTender Corporation d/b/a Adventure Ready Brands history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Tender Corporation d/b/a Adventure Ready Brands?
FDA listed 2 observations on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 820.100 (corrective and preventive action). The opening words of each observation are shown on this page.
Who inspected Tender Corporation d/b/a Adventure Ready Brands?
James W. Whitney is named on this Form 483, for the inspection of Oct 24 – Oct 26, 2018. Each investigator has a profile showing what they cite most.
When was Tender Corporation d/b/a Adventure Ready Brands inspected by FDA?
The inspection ran Oct 24 – Oct 26, 2018, and the Form 483 is dated October 26, 2018.
How do I get the full Form 483 for Tender Corporation d/b/a Adventure Ready Brands?
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