Gerard P. De Leon
FDA investigator
Appears on 9 documents from 2015 to 2017, mostly at sites in Washington. Most often cites control of microbiological contamination (21 CFR 211.113).
- 9
- Documents on file
- 5.7
- Observations per 483
- 2015
- First seen
- 2017
- Most recent
What they cite most
From 38 observations- 21 CFR 211.113Control of microbiological contamination11
- 21 CFR 211.42Design and construction features10
- 21 CFR 211.67Equipment cleaning and maintenance3
- 21 CFR 111.70(b)(2)What specifications must you establish?2
- 21 CFR 211.167Special testing requirements2
- 21 CFR 211.28Personnel responsibilities2
Activity by year
2015: 2, 2016: 3, 2017: 4
Where
Washington 6 · Idaho 2 · Oregon 1
Often inspects with
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Inspection history
9 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2017-08-29 | 483 Kelley-Ross Compounding PharmacyAug 29, 2017 · Seattle, Washington | Seattle, Washington | 7 | |
| 2017-08-02 | 483 Kelley-Ross Compounding PharmacyAug 2, 2017 · Seattle, Washington | Seattle, Washington | 7 | |
| 2017-03-22 | Response RAM Pharma, Inc.Mar 22, 2017 · Idaho Falls, Idaho | Idaho Falls, Idaho | — | |
| 2017-02-07 | 483 RAM Pharma, IncFeb 7, 2017 · Idaho Falls, Idaho | Idaho Falls, Idaho | 13 | |
| 2016-12-16 | 483 Form 483 · FEI 3007500366Dec 16, 2016 · Spokane, Washington | Spokane, Washington | 4 | |
| 2016-08-24 | Response University of Washington Medical Center Inpatient PharmacyAug 24, 2016 · Seattle, Washington | Seattle, Washington | — | |
| 2016-06-10 | 483 Ballard Plaza Pharmacy I, Inc.Jun 10, 2016 · Seattle, Washington | Seattle, Washington | 6 |
About this profile
What does Gerard P. De Leon inspect?
Gerard P. De Leon appears on 9 documents on file covering 7 sites, mostly in Washington.
What do they cite most often?
21 CFR 211.113 (control of microbiological contamination), followed by 21 CFR 211.42 and 21 CFR 211.67.
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 Gerard P. De Leon is dated Aug 29, 2017.