FDA Inspection
STOCKERT GMBHSTOCKERT GMBH – FDA Inspection, Nov 13, 2014
Record Details
This FDA Inspection record concerns STOCKERT GMBH, with an inspection on November 13, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- STOCKERT GMBH
- Inspection Date
- November 13, 2014
- Product Type
- Devices
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ID · 79db9aa1-8b96-4e70-a145-35786f799081
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 905523
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
- 21 CFR 820.30(g)Design validation - production units
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Other FDA inspections of STOCKERT GMBH
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 29, 2022 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 19, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for STOCKERT GMBH
- FDA Inspection 1181969 - 2022-09-29
- FDA Inspection 730733 - 2011-04-19
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