FDA Inspection
Southeast Signal Inc.Southeast Signal Inc. – FDA Inspection, Sep 11, 2018
Record Details
This FDA Inspection record concerns Southeast Signal Inc., with an inspection on September 11, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 9af6e134-bcf7-4b5f-87b2-04f1b009e1db
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1065811
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(j)Design history file
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
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