Karen M. Rodriguez
FDA investigator
Appears on 8 documents from 2015 to 2022, mostly at sites in Florida. Most often cites complaint files (21 CFR 820.198(a)).
- 8
- Documents on file
- 7.5
- Observations per 483
- 2015
- First seen
- 2022
- Most recent
What they cite most
From 60 observations- 21 CFR 820.198(a)Complaint files8
- 21 CFR 820.30(a)Design controls7
- 21 CFR 820.50Purchasing controls6
- 21 CFR 820.100(a)Corrective and preventive action5
- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?4
- 21 CFR 820.22Quality audit3
Activity by year
2015: 1, 2016: 3, 2018: 1, 2019: 2, 2022: 1
Where
Florida 8
Often inspects with
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Inspection history
8 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2022-02-18 | 483 Nikao, IncFeb 18, 2022 · Weston, Florida | Weston, Florida | 6 | |
| 2019-09-27 | 483 Tarmac Products, Inc.Sep 27, 2019 · Miami Gardens, Florida | Miami Gardens, Florida | 17 | |
| 2019-02-15 | 483 Stimwave Technologies Inc 1310 Park Central Blvd S$Feb 15, 2019 · Pompano Beach, Florida | Pompano Beach, Florida | 1 | |
| 2018-07-12 | Amended 483 Heartware, IncJul 12, 2018 · Miami Lakes, Florida | Miami Lakes, Florida | 7 | |
| 2016-09-08 | 483 Powers Medical Devices, LLCSep 8, 2016 · Boca Raton, Florida | Boca Raton, Florida | 6 | |
| 2016-05-10 | 483 Capillus LLCMay 10, 2016 · Doral, Florida | Doral, Florida | 9 | |
| 2016-03-29 | 483 Medscience IncMar 29, 2016 · Delray Beach, Florida | Delray Beach, Florida | 11 |
About this profile
What does Karen M. Rodriguez inspect?
Karen M. Rodriguez appears on 8 documents on file covering 8 sites, mostly in Florida.
What do they cite most often?
21 CFR 820.198(a) (complaint files), followed by 21 CFR 820.30(a) and 21 CFR 820.50.
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 Karen M. Rodriguez is dated Feb 18, 2022.