Home / Inspections / 832254

832254

Transdermal Cap Inc. — FEI 3008699663

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 29, 2013
Fiscal Year
2013
Product Type
Devices
Project Area
Compliance: Devices
Location
Highland Heights, OH (United States)

Facility

Other inspections at this facility

  • 1271850 (VAI Fri Jun 06 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1229921 (VAI Tue Mar 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 988458 (NAI Thu Sep 22 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 932521 (OAI Tue Jun 30 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
230221 CFR 820.20(e)Quality System Procedures
310421 CFR 820.30(j)Design history file
316821 CFR 820.198(a)Complaints
328221 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
367821 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate