FDA Inspection
Jd888 LLCJd888 LLC – FDA Inspection, Dec 21, 2016
Record Details
This FDA Inspection record concerns Jd888 LLC, with an inspection on December 21, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · a1a2fd8b-bf0a-482a-b1f0-185a84dd6f18
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 996733
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
13- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.122(e)Destruction of obsolete labeling
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.130(c)Lot or control number assigned
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(a)Lack of quality control unit
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