Home / Inspections / 1014690

1014690

InvaDerm, Inc. — FEI 3010165760

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 15, 2017
Fiscal Year
2017
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Somerset, NJ (United States)

Facility

Other inspections at this facility

  • 1210509 (VAI Wed Jun 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1084054 (VAI Tue Mar 26 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1011953 (VAI Tue May 30 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
187921 CFR 211.180(c)Records not made readily available to FDA
191421 CFR 211.166(a)Lack of written stability program
435921 CFR 211.170(b)(1)Retention time of reserve samples, in general
440021 CFR 211.186(b)(8)Description of containers, labels, et. al.