FDA Inspection
Pro-Med Instruments GmbhPro-Med Instruments Gmbh – FDA Inspection, Jun 22, 2017
Record Details
This FDA Inspection record concerns Pro-Med Instruments Gmbh, with an inspection on June 22, 2017, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · 8094725e-507c-40bb-989a-e41f2bb6fdd0
Inspection Facts
- Inspection number
- 1015579
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
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Other FDA inspections of Pro-Med Instruments Gmbh
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 6, 2014 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 21, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Pro-Med Instruments Gmbh
- FDA Inspection 905154 - 2014-11-06
- FDA Inspection 790986 - 2012-06-21
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