FDA Inspection
Fomed Industries Inc.Fomed Industries Inc. – FDA Inspection, Jul 11, 2019
Record Details
This FDA Inspection record concerns Fomed Industries Inc., with an inspection on July 11, 2019, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · 0a02ce62-4132-4bec-912a-e1c6aee9e849
Inspection Facts
- Inspection number
- 1098237
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.120Lack of or inadequate procedures for labeling
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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