FDA Inspection
Slice Manufacturing LLCSlice Manufacturing LLC – FDA Inspection, Jul 22, 2019
Record Details
This FDA Inspection record concerns Slice Manufacturing LLC, with an inspection on July 22, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · d33f7b60-ec13-4ea1-ad80-5d35b2cd578e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1097972
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.70(a)Production processes
- 21 CFR 820.184DHR content
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