854499

Aerosprays Inc — FEI 3001236828

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 6, 2013
Fiscal Year
2014
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Las Vegas, NV (United States)

Citations

IDCFRDescription
109821 CFR 211.22(c)Approve or reject procedures or specs
111221 CFR 211.25(a)Training--operations, GMPs, written procedures
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
180121 CFR 211.84(a)Components withheld from use pending release
200421 CFR 211.184(d)Labeling: documentation of exam and review
220521 CFR 211.186(b)(9)Manufacturing Instructions and Specifications
361621 CFR 211.165(d)Acceptance criteria for sampling & testing