Paul M. Kawamoto

FDA investigator

Appears on 7 documents from 2015 to 2021, mostly at sites in Washington. Most often cites corrective and preventive action (21 CFR 820.100).

7
Documents on file
1.9
Observations per 483
2015
First seen
2021
Most recent

What they cite most

From 13 observations
  • 21 CFR 820.100
    Corrective and preventive action
    4
  • 21 CFR 820.198
    Complaint files
    3
  • 21 CFR 820.30(c)
    Design controls
    2
  • 21 CFR 820
    1
  • 21 CFR 803.17(a)(1)
    What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?
    1
  • 21 CFR 803.56
    If I am a manufacturer, in what circumstances must I submit a supplemental or followup report and what are the requirements for such reports?
    1

Activity by year

2015: 1, 2017: 1, 2018: 1, 2019: 3, 2021: 1

Where

Washington 4 · Nevada 2 · California 1

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Inspection history

7 documents, newest first
FirmOpen
483 Ventec Life Systems, IncMay 12, 2021 · Bothell, Washington
483 Wykle, IncMay 10, 2019 · Carson City, Nevada
483 Wykle, Inc. E. College PkwyMay 10, 2019 · Carson City, Nevada
483 Vioguard, Inc.Jan 17, 2019 · Bothell, Washington
483 Philips North America LLCDec 3, 2018 · Bothell, Washington
483 Physio-Control, IncDec 15, 2017 · Redmond, Washington
483 Hitachi Chemical Diagnostics, IncApr 21, 2015 · Mountain View, California

About this profile

What does Paul M. Kawamoto inspect?

Paul M. Kawamoto appears on 7 documents on file covering 5 sites, mostly in Washington.

What do they cite most often?

21 CFR 820.100 (corrective and preventive action), followed by 21 CFR 820.198 and 21 CFR 820.30(c).

Can I read the observations?

Each document page previews the opening words of every observation. The full documents are available to buy, one at a time or together.

How current is this profile?

The most recent document on file for Paul M. Kawamoto is dated May 12, 2021.