Yung W. Chan

FDA investigator

Appears on 2 documents from 2015 to 2017, mostly at sites in California. Most often cites complaint files (21 CFR 820.198).

2
Documents on file
8.0
Observations per 483
2015
First seen
2017
Most recent

What they cite most

From 15 observations
  • 21 CFR 820.198
    Complaint files
    3
  • 21 CFR 820.30
    Design controls
    2
  • 21 CFR 820.50(a)(1)
    Purchasing controls
    2
  • 21 CFR 803.17
    What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?
    1
  • 21 CFR 803.50
    If I am a manufacturer, what reporting requirements apply to me?
    1
  • 21 CFR 807.20(a)
    Who must register and submit a device list?
    1

Activity by year

2015: 1, 2017: 1

Where

California 1 · New Jersey 1

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Inspection history

2 documents, newest first
FirmOpen
483 Becton Dickinson & CompanyJul 6, 2017 · Franklin Lakes, New Jersey
483 Theranos, Inc.Sep 16, 2015 · Newark, California

About this profile

What does Yung W. Chan inspect?

Yung W. Chan appears on 2 documents on file covering 2 sites, mostly in California.

What do they cite most often?

21 CFR 820.198 (complaint files), followed by 21 CFR 820.30 and 21 CFR 820.50(a)(1).

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 Yung W. Chan is dated Jul 6, 2017.