FDA Inspection
SIE AG, Surgical Instrument EngineeringSIE AG, Surgical Instrument Engineering – FDA Inspection, Sep 18, 2014
Record Details
This FDA Inspection record concerns SIE AG, Surgical Instrument Engineering, with an inspection on September 18, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- September 18, 2014
- Product Type
- Devices
View Company Profile
ID · a69fac80-ef89-4a52-9f5d-33776283f04a
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 899746
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
9- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.70(i)Validation of changes to automated process software
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.120Lack of or inadequate procedures for labeling
- 21 CFR 1002.13Failure to submit
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