FDA Inspection
Med Pen Concepts, LLCMed Pen Concepts, LLC – FDA Inspection, Apr 13, 2022
Record Details
This FDA Inspection record concerns Med Pen Concepts, LLC, with an inspection on April 13, 2022, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Med Pen Concepts, LLC
- Inspection Date
- April 13, 2022
- Product Type
- Devices
View Company Profile
ID · d619a167-8183-40c5-bdfe-0e681f5f789a
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1167029
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Enforcement
- Warning Letter
FDA Citations
8- 21 CFR 820.198(a)Complaints
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.120(b)DHR documentation of label release {see also 820.184}
- 21 CFR 820.20(c)Management review dates
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Med Pen Concepts, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| January 24, 2024 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 14, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Med Pen Concepts, LLC
- FDA Inspection 1227633 - 2024-01-24
- FDA Inspection 1209069 - 2023-06-14
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