Home / Inspections / 987996

987996

Ecometics, Inc. — FEI 1250013

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 29, 2016
Fiscal Year
2016
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Norwalk, CT (United States)

Facility

Other inspections at this facility

  • 1207700 (VAI Fri Jun 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1198801 (OAI Mon Feb 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1151267 (OAI Fri Sep 10 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 827540 (VAI Fri Apr 26 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 673112 (VAI Thu Jul 22 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
113321 CFR 211.25(a)GMP Training Frequency
140921 CFR 211.42(c)(4)In-Process Material Area
179021 CFR 211.80(b)Handling and Storage to Prevent Contamination
184221 CFR 211.84(d)(1)Component identity verification
189021 CFR 211.165(e)Test methods
200821 CFR 211.186(a)Written procedures followed
344521 CFR 211.65(a)Equipment construction - reactive surfaces
356521 CFR 211.58Buildings not maintained in good state of repair
357121 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
430621 CFR 211.80(a)Written Procedures Not Followed