FDA Inspection
Ascent Consumer Products Inc.Ascent Consumer Products Inc. – FDA Inspection, Dec 2, 2016
Record Details
This FDA Inspection record concerns Ascent Consumer Products Inc., with an inspection on December 2, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · e8f04f3f-9988-44f2-b1e6-812862e9a0cf
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 996105
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.60Identification procedures, Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 860.7(g)(1)Responsibility to provide valid scientific evidence
- 21 CFR 860.7(g)(2)Rpts of safety & effectiveness, adulteration or misbranding
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