1177962

GoodFibers LLC — FEI 3014741226

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 19, 2022
Fiscal Year
2022
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Phoenix, AZ (United States)

Citations

IDCFRDescription
117721 CFR 211.63Equipment Design, Size and Location
121521 CFR 211.67(b)Written procedures not established/followed
191821 CFR 211.166(a)(2)Stability sample storage conditions described
192021 CFR 211.166(a)(3)Valid stability test methods
202721 CFR 211.192Investigations of discrepancies, failures
360321 CFR 211.160(b)Scientifically sound laboratory controls