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FDA Inspection 980564 — Chartwell Pharmaceuticals Amityville, LLC

Chartwell Pharmaceuticals Amityville, LLC — FEI 2433247

The FDA completed an inspection of Chartwell Pharmaceuticals Amityville, LLC on July 15, 2016 in Amityville, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 15, 2016
Fiscal Year
2016
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Amityville, NY (United States)

Citations

IDCFRDescription
144821 CFR 211.111Establishment of time limitations

Facility

Other inspections at this facility

  • 1193806 (VAI Wed Dec 21 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1079804 (VAI Wed Feb 13 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1011507 (VAI Fri May 05 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 935584 (VAI Mon Jul 20 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 862838 (VAI Wed Oct 30 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

FDA data resources