FDA Inspection
Mapa GmbhMapa Gmbh – FDA Inspection, Sep 19, 2013
Record Details
This FDA Inspection record concerns Mapa Gmbh, with an inspection on September 19, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Mapa Gmbh
- Inspection Date
- September 19, 2013
- Product Type
- Devices
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ID · fdd46094-52b2-4bc3-85a2-24224827a56d
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 851861
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
10- 21 CFR 820.75(c)Process changes - review, evaluation and revalidation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.75(a)Documentation
- 21 CFR 820.30(e)Design review - documentation
- 21 CFR 820.184DHR content
- 21 CFR 820.75(b)(2)Documentation of validated process performance
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Mapa Gmbh
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 5, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Mapa Gmbh
- FDA Inspection 915528 - 2015-02-05
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