FDA Inspection
JK BioscienceJK Bioscience – FDA Inspection, Sep 21, 2018
Record Details
This FDA Inspection record concerns JK Bioscience, with an inspection on September 21, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 850d4770-2f5d-4309-99b0-ae38c424c974
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1066656
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 211.165(d)Acceptance criteria for sampling & testing
- 21 CFR 211.160(a)Deviations from laboratory control requirements
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.68(b)input/output verification
- 21 CFR 211.194(a)(5)Calculations performed are in the records
- 21 CFR 211.160(b)(4)Establishment of calibration procedures
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.160(a)Lab controls established, including changes
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.194(a)(2)Laboratory Test Method Verification
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