FDA Inspection
Aromatica CompanyAromatica Company – FDA Inspection, Sep 8, 2017
Record Details
This FDA Inspection record concerns Aromatica Company, with an inspection on September 8, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 509ef18e-bb74-465f-915c-5c0469a3da16
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1024441
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.166(b)Accelerated stability studies
- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
- 21 CFR 211.67(b)Written procedures fail to include
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