HK Kolmar USA LLC, Scott Township, PA – FDA Inspections

Inspection records and compliance data for HK Kolmar USA LLC in Scott Township, Pennsylvania. 6 FDA inspections on record, last inspected February 09, 2024.

Company Profile

This profile covers HK Kolmar USA LLC based in Scott Township, Pennsylvania, United States.

FDA Inspection History

FDA inspections: 6
OAI: 0
VAI: 4
NAI: 2
Form 483s: 0
Warning letters: 0

First inspected August 18, 2009. Last inspected February 9, 2024.

Most cited issue areas

Absence of Written Procedures1 inspection
Investigations made into any unexplained discrepancy1 inspection
Label reconciliation discrepancies evaluation/investigation1 inspection

FDA inspections (6)

Date	Result	FDA center(s)	Insp. #
February 9, 2024	NAI	Human Drugs · Drug Quality Assurance	1229516
September 8, 2017	NAI	Foods & Cosmetics, Human Drugs · Colors and Cosmetics Technology	1031330
March 4, 2014	VAI	Foods & Cosmetics, Human Drugs · Drug Quality Assurance	867708
October 16, 2012	VAI	Human Drugs · Drug Quality Assurance	804885
October 20, 2009	VAI	Human Drugs · Drug Quality Assurance	623185
August 18, 2009	VAI	Human Drugs · Drug Quality Assurance	607206

FDA documents

No Form 483s, Warning Letters or EIRs on record.

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