FDA Inspection 1041074 — CeramTec GmbH, Medical Products Division

CeramTec GmbH, Medical Products Division — FEI 3002806653

The FDA completed an inspection of CeramTec GmbH, Medical Products Division on Feb 14, 2018 in Plochingen. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 1 citation was issued during this inspection. Product area: Devices.

Inspection details

Classification
No Action Indicated (NAI)
End Date
Feb 14, 2018
Fiscal Year
2018
Product Type
Devices
Project Area
Project Evaluation: Devices
Location
Plochingen (Germany)

Additional details

Postmarket Audit Inspections

Citations

IDCFRDescription
323521 CFR 820.72(a)Equipment control activity documentation

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