Vioguard, Inc.
Form 483 issued January 17, 2019 · Bothell, Washington
- Inspection
- Dec 18, 2018 – Jan 17, 2019
- Investigator
- Paul M. Kawamoto
- Observations
- 2
- Pages
- 10
- FEI number
- 3009521189
In short: On January 17, 2019, FDA issued a Form 483 with 2 observations to Vioguard, Inc. in Bothell, Washington (FEI 3009521189) after an inspection that ran Dec 18, 2018 – Jan 17, 2019. The investigator was Paul M. Kawamoto. Most observations concern design controls; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
2 of 2 observations on this 483 concern design controls.
Most cited: 21 CFR 820.30(h) (1×) · 820.30(c) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures for design transfer…
- 02
Procedures for design input…
This inspection in context
Paul M. Kawamoto
7 documents · 2015–2021
Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in Washington.
The firmVioguard, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.30(h)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Vioguard, Inc.?
FDA listed 2 observations on this Form 483, mostly about design controls. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected Vioguard, Inc.?
Paul M. Kawamoto is named on this Form 483, for the inspection of Dec 18, 2018 – Jan 17, 2019. Each investigator has a profile showing what they cite most.
When was Vioguard, Inc. inspected by FDA?
The inspection ran Dec 18, 2018 – Jan 17, 2019, and the Form 483 is dated January 17, 2019.
How do I get the full Form 483 for Vioguard, Inc.?
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.