FDA Inspection
ALFRED E. MANN FOUNDATION FOR SCIENTIFIC RESEARCH, THEALFRED E. MANN FOUNDATION FOR SCIENTIFIC RESEARCH, THE – FDA Inspection, Aug 18, 2017
Record Details
This FDA Inspection record concerns ALFRED E. MANN FOUNDATION FOR SCIENTIFIC RESEARCH, THE, with an inspection on August 18, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- August 18, 2017
- Product Type
- Devices
- Person
- Sean R. Moynihan (Issuing Officer)
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ID · c50b92ea-b379-4135-880a-01c45cf63ce1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1022615
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.75(a)Documentation
- 21 CFR 820.75(a)Lack of or inadequate process validation
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Other FDA inspections of ALFRED E. MANN FOUNDATION FOR SCIENTIFIC RESEARCH, THE
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 12, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for ALFRED E. MANN FOUNDATION FOR SCIENTIFIC RESEARCH, THE
- FDA Inspection 999623 - 2017-01-12
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