Curium US, LLC, Maryland Heights, MO – FDA Inspections

Inspection records and compliance data for Curium US, LLC in Maryland Heights, Missouri. 11 FDA inspections on record, 1 Form 483, last inspected September 18, 2024.

Company Profile

This profile covers Curium US, LLC based in Maryland Heights, Missouri, United States.

FDA Inspection History

FDA inspections: 11
OAI: 0
VAI: 4
NAI: 6
Unclassified: 1
Form 483s: 1
Warning letters: 0

First inspected February 26, 2010. Last inspected September 18, 2024.

Most cited issue areas

Calibration, Inspection, etc. Procedures Lack of or Inadequ1 inspection
Certificates of Testing (Containers, Closures)1 inspection
Procedures for sterile drug products1 inspection

FDA inspections (11)

Date	Result	FDA center(s)	Insp. #
September 18, 2024	NAI	Medical Devices & Rad Health · Postmarket Assurance: Devices	1250722
August 18, 2023	VAI	Human Drugs · Drug Quality Assurance	1216202
December 18, 2018	NAI	Medical Devices & Rad Health · Compliance: Devices	1080170
November 18, 2016	Not classified	Human Drugs	996388
November 13, 2015	NAI	Human Drugs, Medical Devices & Rad Health · Postmarket Assurance: Devices	966441
June 18, 2014	NAI	Human Drugs, Medical Devices & Rad Health · Drug Quality Assurance	884481
March 27, 2013	NAI	Human Drugs, Medical Devices & Rad Health · Compliance: Devices	828678
August 6, 2012	VAI	Human Drugs · Drug Quality Assurance	793365
May 25, 2011	NAI	Human Drugs · Drug Quality Assurance	726914
May 23, 2011	VAI	Human Drugs · Drug Quality Assurance	726559
February 26, 2010	VAI	Human Drugs · Drug Quality Assurance	649201

FDA documents

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

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