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FDA Inspection 855253 — Chartwell Pharmaceuticals Amityville, LLC

Chartwell Pharmaceuticals Amityville, LLC — FEI 2433247

The FDA completed an inspection of Chartwell Pharmaceuticals Amityville, LLC on October 30, 2013 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
October 30, 2013
Fiscal Year
2014
Product Type
Drugs
Project Area
Bioresearch Monitoring
Location
Amityville, NY (United States)

Additional Details

Postmarket Adverse Drug Experience (PADE)

Citations

IDCFRDescription
435021 CFR 211.160(b)(3)Drug products-sampling procedures/specifications

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))
  • 980564 (VAI Fri Jul 15 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 935584 (VAI Mon Jul 20 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

FDA data resources