Shannon A. Gregory
FDA investigator
Appears on 5 documents from 2015 to 2022, mostly at sites in Kentucky. Most often cites design controls (21 CFR 820.30(a)).
- 5
- Documents on file
- 3.8
- Observations per 483
- 2015
- First seen
- 2022
- Most recent
What they cite most
From 18 observations- 21 CFR 820.30(a)Design controls4
- 21 CFR 820.100(a)Corrective and preventive action2
- 21 CFR 820.184Device history record2
- 21 CFR 820.80Receiving, in-process, and finished device acceptance2
- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?1
- 21 CFR 820.181Device master record1
Activity by year
2015: 1, 2016: 1, 2017: 1, 2021: 1, 2022: 1
Where
Kentucky 3 · Ohio 2
Often inspects with
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Inspection history
5 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2022-01-13 | 483 Innovative Sterilization TechnologiesJan 13, 2022 · Dayton, Ohio | Dayton, Ohio | 2 | |
| 2021-10-29 | 483 Magna Pharmaceuticals, Inc.Oct 29, 2021 · Louisville, Kentucky | Louisville, Kentucky | 1 | |
| 2017-05-02 | 483 Turbo Wheelchair Co. Inc.May 2, 2017 · Louisville, Kentucky | Louisville, Kentucky | 10 | |
| 2016-11-16 | 483 Cardinal SpineNov 16, 2016 · Louisville, Kentucky | Louisville, Kentucky | 2 | |
| 2015-11-04 | 483 Innovative Sterilization TechnologiesNov 4, 2015 · Dayton, Ohio | Dayton, Ohio | 4 |
About this profile
What does Shannon A. Gregory inspect?
Shannon A. Gregory appears on 5 documents on file covering 4 sites, mostly in Kentucky.
What do they cite most often?
21 CFR 820.30(a) (design controls), followed by 21 CFR 820.100(a) and 21 CFR 820.184.
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 Shannon A. Gregory is dated Jan 13, 2022.