Sunita Pandey
FDA investigator
Appears on 5 documents from 2022 to 2025, mostly at sites in Massachusetts. Most often cites design controls (21 CFR 820.30(a)).
- 5
- Documents on file
- 3.6
- Observations per 483
- 2022
- First seen
- 2025
- Most recent
What they cite most
From 17 observations- 21 CFR 820.30(a)Design controls4
- 21 CFR 820.100(a)Corrective and preventive action3
- 21 CFR 820.50Purchasing controls3
- 21 CFR 8202
- 21 CFR 820.120(b)Device labeling2
- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?1
Activity by year
2022: 3, 2024: 1, 2025: 1
Where
Massachusetts 4
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Inspection history
5 documents, newest first| Date | Firm | Location | Observations | Open |
|---|---|---|---|---|
| 2025-12-11 | 483 SMCDec 11, 2025 | — | 3 | |
| 2024-01-24 | 483 Med Pen Concepts, LLC 800 W Cummings Park Ste 5650Jan 24, 2024 · Woburn, Massachusetts | Woburn, Massachusetts | 1 | |
| 2022-10-26 | 483 Primrose Medical Inc.Oct 26, 2022 · East Walpole, Massachusetts | East Walpole, Massachusetts | 2 | |
| 2022-10-26 | 483 Primrose Medical IncOct 26, 2022 · East Walpole, Massachusetts | East Walpole, Massachusetts | 11 | |
| 2022-01-25 | 483 Hightech American Industrial Lattice, Inc.Jan 25, 2022 · Lexington, Massachusetts | Lexington, Massachusetts | 1 |
About this profile
What does Sunita Pandey inspect?
Sunita Pandey appears on 5 documents on file covering 4 sites, mostly in Massachusetts.
What do they cite most often?
21 CFR 820.30(a) (design controls), followed by 21 CFR 820.100(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 Sunita Pandey is dated Dec 11, 2025.