FDA Inspection
Osypka Medical GmbhOsypka Medical Gmbh – FDA Inspection, Dec 1, 2011
Record Details
This FDA Inspection record concerns Osypka Medical Gmbh, with an inspection on December 1, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Osypka Medical Gmbh
- Inspection Date
- December 1, 2011
- Product Type
- Devices
View Company Profile
ID · 7bfb2bfd-940a-49bf-852a-2217864f3af7
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 760029
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.40(a)Not approved or obsolete document retrieval
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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