Viant AS&O Holdings, LLC
Form 483 issued October 23, 2020 · Orchard Park, New York
- Inspection
- Oct 20 – Oct 23, 2020
- Investigator
- Matthew D. Schnittker
- Observations
- 2
- Pages
- 4
- FEI number
- 1000120314
In short: On October 23, 2020, FDA issued a Form 483 with 2 observations to Viant AS&O Holdings, LLC in Orchard Park, New York (FEI 1000120314) after an inspection that ran Oct 20 – Oct 23, 2020. The investigator was Matthew D. Schnittker. Most observations concern cAPA and production & process controls; the most-cited regulation is 21 CFR 820.90 (nonconforming product).
At a glance
CAPA and production & process controls account for 2 of 2 observations.
Most cited: 21 CFR 820.90(a) (1×) · 820.70(i) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures have not been adequately established to control product that does not…
- 02
Software used as part of production has not been validated for its intended use according…
This inspection in context
Matthew D. Schnittker
12 documents · 2015–2025
Cites 820.30(a) (design controls) more than any other section. Most of their documents are for sites in New York.
The firmViant AS&O Holdings, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.90(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Viant AS&O Holdings, LLC?
FDA listed 2 observations on this Form 483, mostly about cAPA and production & process controls. The most-cited regulation is 21 CFR 820.90 (nonconforming product). The opening words of each observation are shown on this page.
Who inspected Viant AS&O Holdings, LLC?
Matthew D. Schnittker is named on this Form 483, for the inspection of Oct 20 – Oct 23, 2020. Each investigator has a profile showing what they cite most.
When was Viant AS&O Holdings, LLC inspected by FDA?
The inspection ran Oct 20 – Oct 23, 2020, and the Form 483 is dated October 23, 2020.
How do I get the full Form 483 for Viant AS&O Holdings, 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.