Dorothy P. Kramer
FDA investigator
Appears on 9 documents from 2022 to 2025, mostly at sites in Florida. Most often cites responsibilities of quality control unit (21 CFR 211.22(d)).
- 9
- Documents on file
- 4.2
- Observations per 483
- 2022
- First seen
- 2025
- Most recent
What they cite most
From 38 observations- 21 CFR 211.22(d)Responsibilities of quality control unit5
- 21 CFR 211.100(a)Written procedures; deviations4
- 21 CFR 211.67Equipment cleaning and maintenance4
- 21 CFR 211.84(a)Testing and approval or rejection of components, drug product containers, and closures4
- 21 CFR 211.68(a)Automatic, mechanical, and electronic equipment3
- 21 CFR 211.160(a)General requirements2
Activity by year
2022: 3, 2023: 3, 2024: 2, 2025: 1
Where
Florida 5 · North Carolina 1 · Oklahoma 1 · South Carolina 1 · Spain 1
Often inspects with
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Inspection history
9 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2025-07-28 | 483 DOH Central PharmacyJul 28, 2025 · Tallahassee, Florida | Tallahassee, Florida | 6 | |
| 2024-11-22 | 483 SmartScience Laboratories, Inc.Nov 22, 2024 · Tampa, Florida | Tampa, Florida | 8 | |
| 2024-01-19 | 483 Kesin PharmaJan 19, 2024 · Oldsmar, Florida | Oldsmar, Florida | 6 | |
| 2023-11-03 | 483 Halocarbon Life Sciences, LLCNov 3, 2023 · North Augusta, South Carolina | North Augusta, South Carolina | 1 | |
| 2023-09-22 | 483 Rovi Pharma Industrial Services S.A.Sep 22, 2023 · San Sebastian De Los Reyes, Spain | San Sebastian De Los Reyes, Spain | 2 | |
| 2023-07-28 | 483 King Bio IncJul 28, 2023 · Asheville, North Carolina | Asheville, North Carolina | 2 | |
| 2022-12-16 | 483 RAPHA Health Network International, IncDec 16, 2022 · Doral, Florida | Doral, Florida | 4 |
About this profile
What does Dorothy P. Kramer inspect?
Dorothy P. Kramer appears on 9 documents on file covering 9 sites, mostly in Florida.
What do they cite most often?
21 CFR 211.22(d) (responsibilities of quality control unit), followed by 21 CFR 211.100(a) and 21 CFR 211.67.
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 Dorothy P. Kramer is dated Jul 28, 2025.