FDA Inspection
ChromaDex AnalyticsChromaDex Analytics – FDA Inspection, Feb 29, 2012
Record Details
This FDA Inspection record concerns ChromaDex Analytics, with an inspection on February 29, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- ChromaDex Analytics
- Inspection Date
- February 29, 2012
- Product Type
- Drugs
View Company Profile
ID · ede02b4d-3726-485b-ad2b-366172d63a11
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 771632
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 111.30(b)Equipment - automated - suitability
- 21 CFR 111.320(b)Examination, testing; scientifically valid
- 21 CFR 111.105(i)QC required operations production and process control
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