FDA Inspection
Atlas BioscienceAtlas Bioscience – FDA Inspection, Oct 17, 2018
Record Details
This FDA Inspection record concerns Atlas Bioscience, with an inspection on October 17, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 2a63d326-b584-4990-a75e-7b3c2f55d8db
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1068959
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.160(a)Deviations from laboratory control requirements
- 21 CFR 211.194(a)(4)Complete Test Data
- 21 CFR 211.160(b)(4)Establishment of calibration procedures
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