FDA Inspection
FACOSPARFACOSPAR – FDA Inspection, Jan 22, 2015
Record Details
This FDA Inspection record concerns FACOSPAR, with an inspection on January 22, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- FACOSPAR
- Inspection Date
- January 22, 2015
- Product Type
- Drugs
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ID · 320cc105-a774-4d7b-b8dc-ef30fe00cdd5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 913216
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
10- 21 CFR 211.122(d)Label storage access limited to authorized personnel
- 21 CFR 211.68(b)Backup data not assured as exact and complete
- 21 CFR 211.84(d)(2)Testing Each Component for Conformity with Specs
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(b)Written procedures not established/followed
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