Mary R. Hole
FDA investigator
Appears on 7 documents from 2013 to 2017, mostly at sites in California. Most often cites design controls (21 CFR 820.30).
- 7
- Documents on file
- 9.0
- Observations per 483
- 2013
- First seen
- 2017
- Most recent
What they cite most
From 62 observations- 21 CFR 820.30Design controls15
- 21 CFR 820.100Corrective and preventive action7
- 21 CFR 820.198(a)Complaint files5
- 21 CFR 820.22Quality audit4
- 21 CFR 820.50Purchasing controls4
- 21 CFR 806.10(a)(1)Reports of corrections and removals2
Activity by year
2013: 1, 2015: 4, 2016: 1, 2017: 1
Where
California 7
Often inspects with
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Inspection history
7 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2017-03-17 | 483 UCP Bioscicnces, IncMar 17, 2017 · San Jose, California | San Jose, California | 4 | |
| 2016-07-06 | 483 Helio USA IncJul 6, 2016 · San Jose, California | San Jose, California | 14 | |
| 2015-09-16 | 483 Theranos, Inc.Sep 16, 2015 · Newark, California | Newark, California | 9 | |
| 2015-07-29 | 483 Affymetrix, IncJul 29, 2015 · Santa Clara, California | Santa Clara, California | 2 | |
| 2015-05-12 | 483 Helio USA Inc.May 12, 2015 · San Jose, California | San Jose, California | 22 | |
| 2015-04-17 | 483 The Medicines CompanyApr 17, 2015 · Redwood City, California | Redwood City, California | 8 | |
| 2013-05-30 | 483 Intuitive Surgical, Inc.May 30, 2013 · Sunnyvale, California | Sunnyvale, California | 4 |
About this profile
What does Mary R. Hole inspect?
Mary R. Hole appears on 7 documents on file covering 6 sites, mostly in California.
What do they cite most often?
21 CFR 820.30 (design controls), followed by 21 CFR 820.100 and 21 CFR 820.198(a).
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 Mary R. Hole is dated Mar 17, 2017.