FDA Inspection
Advanced Apothecaries, Inc.Advanced Apothecaries, Inc. – FDA Inspection, Jan 26, 2012
Record Details
This FDA Inspection record concerns Advanced Apothecaries, Inc., with an inspection on January 26, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Advanced Apothecaries, Inc.
- Inspection Date
- January 26, 2012
- Product Type
- Drugs
View Company Profile
ID · 3a00a95f-415f-4908-865e-56ba8013599f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 764956
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
8- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.84(a)Components withheld from use pending release
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.130(c)Lot or control number assigned
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.100(a)Approval and review of procedures
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