Tender Corporation d/b/a Adventure Ready Brands
Form 483 issued April 26, 2023 · Littleton, New Hampshire
- Inspection
- Apr 3 – Apr 26, 2023
- Investigator
- Erik W. Koester
- Observations
- 4
- Pages
- 5
- FEI number
- 1250045
In short: On April 26, 2023, FDA issued a Form 483 with 4 observations to Tender Corporation d/b/a Adventure Ready Brands in Littleton, New Hampshire (FEI 1250045) after an inspection that ran Apr 3 – Apr 26, 2023. The investigator was Erik W. Koester. Most observations concern materials and production; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
Materials and production account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
The identity of each component of a drug product is not verified by conducting at least…
- 02
Sampling procedures are deficient regarding sampling components from the top, middle, and…
- 03
Written production and process control procedures are not followed in the execution of production…
- 04
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
This inspection in context
Erik W. Koester
40 documents · 2006–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Massachusetts.
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 211.84(d)(1)
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 4 observations on this Form 483, mostly about materials, production and facilities & equipment. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected Tender Corporation d/b/a Adventure Ready Brands?
Erik W. Koester is named on this Form 483, for the inspection of Apr 3 – Apr 26, 2023. 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 Apr 3 – Apr 26, 2023, and the Form 483 is dated April 26, 2023.
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.