Jennifer M. Gogley
FDA investigator
Appears on 8 documents from 2007 to 2019, mostly at sites in California. Most often cites design and construction features (21 CFR 211.42).
- 8
- Documents on file
- 8.4
- Observations per 483
- 2007
- First seen
- 2019
- Most recent
What they cite most
From 67 observations- 21 CFR 211.42Design and construction features9
- 21 CFR 820.30Design controls8
- 21 CFR 211.113Control of microbiological contamination7
- 21 CFR 211.160General requirements5
- 21 CFR 211.192Production record review4
- 21 CFR 211.22Responsibilities of quality control unit4
Activity by year
2007: 1, 2012: 1, 2014: 1, 2015: 2, 2017: 1, 2019: 2
Where
California 7 · South Korea 1
Often inspects with
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Inspection history
8 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2019-10-18 | 483 Huons Co., Ltd.Oct 18, 2019 · Jecheon-si, South Korea | Jecheon-si, South Korea | 5 | |
| 2019-03-26 | 483 McGuff Pharmaceuticals, Inc.Mar 26, 2019 · Santa Ana, California | Santa Ana, California | 7 | |
| 2017-03-31 | 483 Amphastar Pharmaceuticals, IncMar 31, 2017 · Rancho Cucamonga, California | Rancho Cucamonga, California | 20 | |
| 2015-07-08 | 483 Hartley Medical Center Pharmacy, IncorporatedJul 8, 2015 · Long Beach, California | Long Beach, California | 6 | |
| 2015-01-15 | 483 Pyramid Laboratories, Inc.Jan 15, 2015 · Costa Mesa, California | Costa Mesa, California | 13 | |
| 2014-07-02 | 483 South Coast Specialty Compounding, Inc. (Park Pharmacy and Compounding)Jul 2, 2014 · Irvine, California | Irvine, California | 7 | |
| 2012-04-24 | 483 Teva Parenteral Medicines, Inc.Apr 24, 2012 · Irvine, California | Irvine, California | 2 |
About this profile
What does Jennifer M. Gogley inspect?
Jennifer M. Gogley appears on 8 documents on file covering 8 sites, mostly in California.
What do they cite most often?
21 CFR 211.42 (design and construction features), followed by 21 CFR 820.30 and 21 CFR 211.113.
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 Jennifer M. Gogley is dated Oct 18, 2019.