FDA Inspection
Narang Medical Ltd.Narang Medical Ltd. – FDA Inspection, May 31, 2018
Record Details
This FDA Inspection record concerns Narang Medical Ltd., with an inspection on May 31, 2018, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · 7848f214-5af8-46fe-aaf1-f53668758aa8
Inspection Facts
- Inspection number
- 1053841
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 820.30(b)Design plans - Lack of or inadequate
- 21 CFR 820.30(c)Design input - Lack of or inadequate procedures
- 21 CFR 820.30(d)Design output - documentation
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - documentation
- 21 CFR 820.30(g)Design validation - documentation
- 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
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