Valisure, LLC
Form 483 issued July 6, 2021 · New Haven, Connecticut
- Inspection
- May 26 – Jul 6, 2021
- Investigators
- Jonah S. Ufferfilge· Robert J. Martin· Sarah E. Venti
- Observations
- 6
- Pages
- 9
In short: On July 6, 2021, FDA issued a Form 483 with 6 observations to Valisure, LLC in New Haven, Connecticut after an inspection that ran May 26 – Jul 6, 2021. The investigators were Jonah S. Ufferfilge, Robert J. Martin and Sarah E. Venti. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Facilities & equipment and laboratory controls account for 3 of 5 observations.
Most cited: 21 CFR 211.68 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
...,_,.,.,AA= ~ OATelSSUEll The firm's equipment…
- 03
·--~~- The firm has failed to adequately control data access within analytical equipment used for the…
- 04
The firm's laboratory investigations…
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 firmValisure, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Valisure, LLC?
FDA listed 6 observations on this Form 483, mostly about facilities & equipment, laboratory controls and quality system. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Valisure, LLC?
Jonah S. Ufferfilge, Robert J. Martin and Sarah E. Venti are named on this Form 483, for the inspection of May 26 – Jul 6, 2021. Each investigator has a profile showing what they cite most.
When was Valisure, LLC inspected by FDA?
The inspection ran May 26 – Jul 6, 2021, and the Form 483 is dated July 6, 2021.
How do I get the full Form 483 for Valisure, 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.