Med Pen Concepts, LLC 800 W Cummings Park Ste 5650
Form 483 issued January 24, 2024 · Woburn, Massachusetts
- Inspection
- Jan 9 – Jan 24, 2024
- Investigator
- Sunita Pandey
- Observations
- 1
- Pages
- 12
- FEI number
- 3015602723
In short: On January 24, 2024, FDA issued a Form 483 with 1 observation to Med Pen Concepts, LLC 800 W Cummings Park Ste 5650 in Woburn, Massachusetts (FEI 3015602723) after an inspection that ran Jan 9 – Jan 24, 2024. The investigator was Sunita Pandey. Most observations concern design controls; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
1 of 1 observations on this 483 concern design controls.
Most cited: 21 CFR 820.30(f) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures for design verification have…
This inspection in context
Sunita Pandey
5 documents · 2022–2025
Cites 820.30(a) (design controls) more than any other section. Most of their documents are for sites in Massachusetts.
The firmMed Pen Concepts, LLC 800 W Cummings Park Ste 5650 history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.30(f)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Med Pen Concepts, LLC 800 W Cummings Park Ste 5650?
FDA listed 1 observation on this Form 483, mostly about design controls. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected Med Pen Concepts, LLC 800 W Cummings Park Ste 5650?
Sunita Pandey is named on this Form 483, for the inspection of Jan 9 – Jan 24, 2024. Each investigator has a profile showing what they cite most.
When was Med Pen Concepts, LLC 800 W Cummings Park Ste 5650 inspected by FDA?
The inspection ran Jan 9 – Jan 24, 2024, and the Form 483 is dated January 24, 2024.
How do I get the full Form 483 for Med Pen Concepts, LLC 800 W Cummings Park Ste 5650?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.