Ventec Life Systems, Inc
Form 483 issued May 12, 2021 · Bothell, Washington
- Inspection
- Mar 22 – May 12, 2021
- Investigator
- Paul M. Kawamoto
- Observations
- 2
- Pages
- 5
- FEI number
- 3013095415
In short: On May 12, 2021, FDA issued a Form 483 with 2 observations to Ventec Life Systems, Inc in Bothell, Washington (FEI 3013095415) after an inspection that ran Mar 22 – May 12, 2021. The investigator was Paul M. Kawamoto. Most observations concern cAPA; the most-cited regulation is 21 CFR 803.17 (what are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?).
At a glance
2 of 2 observations on this 483 concern capa.
Most cited: 21 CFR 803.17(a)(1) (1×) · 820.100(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
The written MDR Procedure does not include an internal system which provides for timely and effective…
- 02
Procedures for corrective and preventive action have…
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 firmVentec Life Systems, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 803.17(a)(1)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Ventec Life Systems, Inc?
FDA listed 2 observations on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 803.17 (what are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?). The opening words of each observation are shown on this page.
Who inspected Ventec Life Systems, Inc?
Paul M. Kawamoto is named on this Form 483, for the inspection of Mar 22 – May 12, 2021. Each investigator has a profile showing what they cite most.
When was Ventec Life Systems, Inc inspected by FDA?
The inspection ran Mar 22 – May 12, 2021, and the Form 483 is dated May 12, 2021.
How do I get the full Form 483 for Ventec Life Systems, Inc?
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