Tender Corporation d/b/a Adventure Ready Brands
Form 483 issued November 25, 2019 · Littleton, New Hampshire
- Inspection
- Nov 12 – Nov 25, 2019
- Investigators
- Jonah S. Ufferfilge· Sean R. Marcsisin
- Observations
- 6
- Pages
- 10
- FEI number
- 1250045
In short: On November 25, 2019, FDA issued a Form 483 with 6 observations to Tender Corporation d/b/a Adventure Ready Brands in Littleton, New Hampshire (FEI 1250045) after an inspection that ran Nov 12 – Nov 25, 2019. The investigators were Jonah S. Ufferfilge and Sean R. Marcsisin. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and quality system account for 5 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications designed to assure…
- 02
Laboratory records are deficient in that they do not include a complete record of all…
- 03
Established test procedures and laboratory control…
- 04
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
This inspection in context
Jonah S. Ufferfilge
17 documents · 2019–2023
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Connecticut.
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 211.160(b)
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 6 observations on this Form 483, mostly about laboratory controls, quality system and production. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Tender Corporation d/b/a Adventure Ready Brands?
Jonah S. Ufferfilge and Sean R. Marcsisin are named on this Form 483, for the inspection of Nov 12 – Nov 25, 2019. 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 Nov 12 – Nov 25, 2019, and the Form 483 is dated November 25, 2019.
How do I get the full Form 483 for Tender Corporation d/b/a Adventure Ready Brands?
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.