Med Pen Concepts, LLC 800 W Cummings Park Ste 5650
FDA inspection history in Woburn, Massachusetts, 2022 to 2024
- 1
- Form 483
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2022: one warning letter; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2022–24One warning letter and one Form 483, at Woburn, Massachusetts.
Cited most
Across all Med Pen Concepts, LLC 800 W Cummings Park Ste 5650 observations on file
- 21 CFR 820.30(f)Design controls1
The complete Med Pen Concepts, LLC 800 W Cummings Park Ste 5650 file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Woburn, Massachusetts
One Form 483 and one warning letter · 2022 to 2024 · 1 observation
Latest: Form 483, Jan 24, 2024 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-01-24 | 483 Form 483 | Woburn, Massachusetts | 1 | $99 |
| 2022-09-15 | Warning letter Warning letter | Woburn, Massachusetts | — | $99 |
Investigators on these documents
FEI number 3015602723 · most recent document Jan 24, 2024
About Med Pen Concepts, LLC 800 W Cummings Park Ste 5650
How many FDA Form 483s has Med Pen Concepts, LLC 800 W Cummings Park Ste 5650 received?
FDA Intel has 1 Form 483 on file for Med Pen Concepts, LLC 800 W Cummings Park Ste 5650; the most recent is dated Jan 24, 2024.
When was Med Pen Concepts, LLC 800 W Cummings Park Ste 5650 last inspected by FDA?
The most recent FDA inspection document on file for Med Pen Concepts, LLC 800 W Cummings Park Ste 5650 is a Form 483 dated Jan 24, 2024, for the site in Woburn, Massachusetts.
What did FDA cite at Med Pen Concepts, LLC 800 W Cummings Park Ste 5650?
The regulations cited most in the observations on file for Med Pen Concepts, LLC 800 W Cummings Park Ste 5650 are 21 CFR 820.30(f) (Design controls), 1 time.
Has Med Pen Concepts, LLC 800 W Cummings Park Ste 5650 received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Med Pen Concepts, LLC 800 W Cummings Park Ste 5650; the most recent is dated Sep 15, 2022.