FDA Inspection
Deroyal Industries, Inc. LafolletteDeroyal Industries, Inc. Lafollette – FDA Inspection, Sep 2, 2010
Record Details
This FDA Inspection record concerns Deroyal Industries, Inc. Lafollette, with an inspection on September 2, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- September 2, 2010
- Product Type
- Devices
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ID · 55d584a7-5796-4cc9-9e3c-87d0d3f12e24
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 679581
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.30(b)Design plans - Lack of or inadequate
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.30(j)Design history file
- 21 CFR 820.30(g)Design validation - production units
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Other FDA inspections of Deroyal Industries, Inc. Lafollette
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 12, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
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