815981

Keystone Industries — FEI 3010002722

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 6, 2013
Fiscal Year
2013
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Gibbstown, NJ (United States)

Citations

IDCFRDescription
113421 CFR 211.25(b)Supervisor Training/Education/Experience
144821 CFR 211.111Establishment of time limitations
192021 CFR 211.166(a)(3)Valid stability test methods
192621 CFR 211.166(b)Adequate number of batches on stability
440021 CFR 211.186(b)(8)Description of containers, labels, et. al.