FDA Inspection
Med Pen Concepts, LLCMed Pen Concepts, LLC – FDA Inspection, Jan 24, 2024
Record Details
This FDA Inspection record concerns Med Pen Concepts, LLC, with an inspection on January 24, 2024, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · e4f21bc8-6c65-4f59-9aa0-cf0b1e9ab05b
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1227633
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
12- 21 CFR 820.80(b)Incoming acceptance records, documentation
- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
Showing 10 of 12 citations.
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Med Pen Concepts, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| June 14, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 13, 2022 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Med Pen Concepts, LLC
- FDA Inspection 1209069 - 2023-06-14
- FDA Inspection 1167029 - 2022-04-13
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.