Tender Corporation d/b/a Adventure Ready Brands
Form 483 issued September 23, 2021 · Littleton, New Hampshire
- Inspection
- Sep 13 – Sep 23, 2021
- Investigators
- Annet R. Rajan· Saleem A. Akhtar
- Observations
- 9
- Pages
- 14
- FEI number
- 1250045
In short: On September 23, 2021, FDA issued a Form 483 with 9 observations to Tender Corporation d/b/a Adventure Ready Brands in Littleton, New Hampshire (FEI 1250045) after an inspection that ran Sep 13 – Sep 23, 2021. The investigators were Annet R. Rajan and Saleem A. Akhtar. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.25 (personnel qualifications).
At a glance
6 of 9 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observation- 01
Laboratory records are deficient in that they do not include the initials and signature of the…
- 02
The written stability testing…
- 03
Procedures describing the handling of all written and oral complaints regarding a drug…
- 04
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Annet R. Rajan
16 documents · 2020–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in New Jersey.
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 211.194(a)(8)
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 9 observations on this Form 483, mostly about quality system, laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.25 (personnel qualifications). The opening words of each observation are shown on this page.
Who inspected Tender Corporation d/b/a Adventure Ready Brands?
Annet R. Rajan and Saleem A. Akhtar are named on this Form 483, for the inspection of Sep 13 – Sep 23, 2021. 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 Sep 13 – Sep 23, 2021, and the Form 483 is dated September 23, 2021.
How do I get the full Form 483 for Tender Corporation d/b/a Adventure Ready Brands?
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