Laura Fontan
FDA investigator
Appears on 8 documents from 2017 to 2022, most often at sites in California. Most often cites written procedures; deviations (21 CFR 211.100).
- 8
- Documents on file
- 4.0
- Observations per 483
- 2017
- First seen
- 2022
- Most recent
What they cite most
From 28 observations- 21 CFR 211.100Written procedures; deviations6
- 21 CFR 211.113Control of microbiological contamination5
- 21 CFR 211.160General requirements3
- 21 CFR 211.42Design and construction features3
- 21 CFR 211.67Equipment cleaning and maintenance3
- 21 CFR 211.192Production record review2
Activity by year
2017: 2, 2018: 3, 2019: 1, 2021: 1, 2022: 1
Where
California 2 · Austria 1 · Belgium 1 · Florida 1 · India 1 · Ireland 1
Often inspects with
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Inspection history
8 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2022-12-09 | 483 BioMarin Pharmaceutical Inc.Dec 9, 2022 · Novato, California | Novato, California | 2 | |
| 2021-07-02 | EIR Pfizer Manufacturing Belgium NVJul 2, 2021 · Puurs, Belgium | Puurs, Belgium | — | |
| 2019-06-14 | 483 CORERX, INC.Jun 14, 2019 · CLEARWATER, Florida | CLEARWATER, Florida | 6 | |
| 2018-05-01 | 483 Biocon Limited Special Economic Zone, Plot No, 2-5, Phase IVMay 1, 2018 · Bangalore, India | Bangalore, India | 2 | |
| 2018-03-16 | 483 Eli Lilly Kinsale LimitedMar 16, 2018 · Kinsale, Ireland | Kinsale, Ireland | 3 | |
| 2018-02-20 | 483 Sandoz GmbHFeb 20, 2018 · Langkampfen, Austria | Langkampfen, Austria | 4 | |
| 2017-05-16 | 483 Amgen, IncMay 16, 2017 · Thousand Oaks, California | Thousand Oaks, California | 5 |
About this profile
What does Laura Fontan inspect?
Laura Fontan appears on 8 documents on file covering 8 sites, most often in California.
What do they cite most often?
21 CFR 211.100 (written procedures; deviations), followed by 21 CFR 211.113 and 21 CFR 211.160.
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 Laura Fontan is dated Dec 9, 2022.