Amanda L. Fyles
FDA investigator
Appears on 5 documents from 2017 to 2019, mostly at sites in California. Most often cites testing and release for distribution (21 CFR 211.165).
- 5
- Documents on file
- 8.6
- Observations per 483
- 2017
- First seen
- 2019
- Most recent
What they cite most
From 43 observations- 21 CFR 211.165Testing and release for distribution6
- 21 CFR 820.30Design controls5
- 21 CFR 211.100Written procedures; deviations4
- 21 CFR 211.160General requirements4
- 21 CFR 211.22Responsibilities of quality control unit4
- 21 CFR 211.68Automatic, mechanical, and electronic equipment4
Activity by year
2017: 2, 2018: 1, 2019: 2
Where
California 5
Often inspects with
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Inspection history
5 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2019-04-11 | 483 PYRAMID Laboratories, Inc.Apr 11, 2019 · Costa Mesa, California | Costa Mesa, California | 1 | |
| 2019-01-18 | 483 Teva Parenteral Medicines, Inc.Jan 18, 2019 · Irvine, California | Irvine, California | 4 | |
| 2018-06-29 | 483 B. Braun US Pharmaceutical Manufacturing LLCJun 29, 2018 · Irvine, California | Irvine, California | 8 | |
| 2017-05-26 | 483 Alliance Medical Products, Inc. (dba Siegfried Irvine)May 26, 2017 · Irvine, California | Irvine, California | 10 | |
| 2017-03-31 | 483 Amphastar Pharmaceuticals, IncMar 31, 2017 · Rancho Cucamonga, California | Rancho Cucamonga, California | 20 |
About this profile
What does Amanda L. Fyles inspect?
Amanda L. Fyles appears on 5 documents on file covering 5 sites, mostly in California.
What do they cite most often?
21 CFR 211.165 (testing and release for distribution), followed by 21 CFR 820.30 and 21 CFR 211.100.
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 Amanda L. Fyles is dated Apr 11, 2019.