FDA Inspection
DiaPharma Group IncDiaPharma Group Inc – FDA Inspection, Mar 8, 2011
Record Details
This FDA Inspection record concerns DiaPharma Group Inc, with an inspection on March 8, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- DiaPharma Group Inc
- Inspection Date
- March 8, 2011
- Product Type
- Devices
View Company Profile
ID · 79edb58b-f83d-409f-90da-800a7af2be94
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 712065
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
9- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.25(a)Personnel
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
Full citation text and observation details available on the Dashboard.
Other FDA inspections of DiaPharma Group Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| February 25, 2026 | Not classified | Cincinnati District Office | |
| April 29, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 31, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 11, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for DiaPharma Group Inc
- FDA Inspection 1306606 - 2026-02-25
- FDA Inspection 1171225 - 2022-04-29
- FDA Inspection 940414 - 2015-08-31
- FDA Inspection 749173 - 2011-10-11
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