FDA Inspection
Advanced Crystal TherapiesAdvanced Crystal Therapies – FDA Inspection, Apr 25, 2017
Record Details
This FDA Inspection record concerns Advanced Crystal Therapies, with an inspection on April 25, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 7620620d-81ec-49af-a5d8-cae2b832cb9e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1009114
- FDA center
- Human Drugs
- Project area
- Unapproved and Misbranded Drugs
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.84(a)Components withheld from use pending release
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.22(a)Approve or reject components, products
- 21 CFR 211.100(a)Absence of Written Procedures
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