1128891

Savings Distributors LLC — FEI 3011497486

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 27, 2020
Fiscal Year
2020
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Islandia, NY (United States)

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
111121 CFR 211.25(a)Training , Education , Experience overall
119421 CFR 211.42(c)Defined areas of adequate size for operations
136121 CFR 211.100(a)Absence of Written Procedures
149621 CFR 211.122(a)Sampling/testing of labeling/packaging materials
191421 CFR 211.166(a)Lack of written stability program
200921 CFR 211.188Prepared for each batch, include complete information
362821 CFR 211.170(a)(3)Retention times for actives of OTC drugs
434221 CFR 211.142(b)Storage under appropriate conditions