Curium US, LLC – FDA Inspection, Aug 6, 2012

Record Details

This FDA Inspection record concerns Curium US, LLC, with an inspection on August 6, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: Curium US, LLC
Inspection Date: August 6, 2012
Product Type: Drugs
Office: Center for Drug Evaluation and Research

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ID · 478d9557-cfde-4e3b-b53c-83b26d3cc12a

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number: 793365
FDA center: Human Drugs
Project area: Drug Quality Assurance

FDA Citations

21 CFR 211.84(d)(3)Certificates of Testing (Containers, Closures)
21 CFR 211.113(b)Procedures for sterile drug products
21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
21 CFR 820.20(e)Quality System Procedures
21 CFR 211.67(b)Written procedures not established/followed
21 CFR 211.100(b)SOPs not followed / documented
21 CFR 211.192Written record of investigation incomplete

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Other FDA inspections of Curium US, LLC

Date	Classification	Office	Project area
September 18, 2024	NAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
August 18, 2023	VAI	Center for Drug Evaluation and Research	Drug Quality Assurance
December 18, 2018	NAI	Center for Devices and Radiological Health	Compliance: Devices
November 18, 2016	Not classified	Kansas City District Office
November 13, 2015	NAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices