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HK Kolmar USA, LLC — FDA Facility Profile

FEI 1000221288

HK Kolmar USA, LLC is an FDA-registered facility (FEI 1000221288) located in Olyphant, PA, US. Registered operations: LABEL; MANUFACTURE; PACK. RegDataLab tracks 6 FDA inspections at this facility.

Facility Details

Location
Olyphant, PA (US)
Registration Expires
December 31, 2026
Operations
LABEL; MANUFACTURE; PACK
Source
both

Recent inspections

  • 1229516 (NAI Fri Feb 09 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1031330 (NAI Fri Sep 08 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 867708 (NAI Tue Mar 04 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 804885 (VAI Tue Oct 16 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 623185 (VAI Tue Oct 20 2009 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 607206 (VAI Tue Aug 18 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Import refusals

  • 554-7537585-7/41/1 (Wed Nov 08 2017 00:00:00 GMT+0000 (Coordinated Universal Time) — Cosmetics)
  • 554-7537585-7/61/1 (Wed Nov 08 2017 00:00:00 GMT+0000 (Coordinated Universal Time) — Cosmetics)
  • 554-7536222-8/511/1 (Tue Aug 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 554-7536222-8/541/1 (Tue Aug 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 554-7536222-8/581/1 (Tue Aug 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 300-7170869-5/1/1B (Wed Jan 09 2013 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources