Michelle A. Krayer
FDA investigator
Appears on 11 documents from 2019 to 2024, mostly at sites in Texas. Most often cites responsibilities of quality control unit (21 CFR 211.22).
- 11
- Documents on file
- 4.7
- Observations per 483
- 2019
- First seen
- 2024
- Most recent
What they cite most
From 52 observations- 21 CFR 211.22Responsibilities of quality control unit7
- 21 CFR 211.192Production record review5
- 21 CFR 211.165(a)Testing and release for distribution4
- 21 CFR 211.67Equipment cleaning and maintenance4
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures4
- 21 CFR 211.100Written procedures; deviations3
Activity by year
2019: 2, 2020: 1, 2021: 2, 2022: 2, 2023: 3, 2024: 1
Where
Texas 10 · Oklahoma 1
Often inspects with
Patty P. Kaewussdangkul· Shelby N. Turner· Ariel Cruz Figueroa
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Inspection history
11 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2024-03-19 | 483 Qualgen, LLCMar 19, 2024 · Edmond, Oklahoma | Edmond, Oklahoma | 14 | |
| 2023-09-20 | 483 ARG Laboratories, IncSep 20, 2023 · Dallas, Texas | Dallas, Texas | 7 | |
| 2023-03-31 | 483 Fruit of the Earth, Inc.Mar 31, 2023 · Grand Prairie, Texas | Grand Prairie, Texas | 1 | |
| 2023-02-07 | 483 TAKA USA, INC. dba Cosmetic InnovationsFeb 7, 2023 · Coppell, Texas | Coppell, Texas | 9 | |
| 2022-09-22 | 483 Mission Pharmacal CompanySep 22, 2022 · Boerne, Texas | Boerne, Texas | 2 | |
| 2022-03-01 | 483 Dhaliwal Pharmaceuticals Laboratories, LLCMar 1, 2022 · MESQUITE, Texas | MESQUITE, Texas | 1 | |
| 2021-09-27 | 483 Taka USA Inc. dba Cosmetic InnovationsSep 27, 2021 · Coppell, Texas | Coppell, Texas | 7 |
About this profile
What does Michelle A. Krayer inspect?
Michelle A. Krayer appears on 11 documents on file covering 8 sites, mostly in Texas.
What do they cite most often?
21 CFR 211.22 (responsibilities of quality control unit), followed by 21 CFR 211.192 and 21 CFR 211.165(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 Michelle A. Krayer is dated Mar 19, 2024.