Drug factory · FDA FEI 3002807779

GE Healthcare AS

Nycoveien 1, Oslo, Norway

Problems found, fixed voluntarily at FDA's last inspection, Apr 23, 2024.

Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.

8 drug inspections on record since 2009: 2 with no problems, 6 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Cobaltous Cation and Technetium Tc-99m Exametazime	Makes it	Medi-Physics Inc. dba GE Healthcare.	17156-025
Fluciclovine F-18	Makes the active ingredient	Blue Earth Diagnostics	69932-001
Flutemetamol F-18	Makes it and tests it	Medi-Physics Inc. dba GE Healthcare.	17156-067
Gadodiamide	Makes it, tests it, packages it and labels it	GE Healthcare Inc.	0407-0690
Gadolinium Cation (3+)	Makes it, tests it, packages it and labels it	GE Healthcare Inc.	0407-1066, 0407-2943
Human Albumin Microspheres and Perflutren	Makes it	GE Healthcare Inc.	0407-2707
Iodixanol	Makes it	GE Healthcare Inc.	0407-2222, 0407-2223
Iohexol	Makes it	GE Healthcare Inc.	0407-1411, 0407-1412, 0407-1413 +1
Technetium Tc-99m Exametazime	Makes it and makes the active ingredient	Medi-Physics Inc. dba GE Healthcare.	17156-022
Tetrofosmin	Makes it	Medi-Physics Inc. dba GE Healthcare.	17156-024, 17156-026

Ended	Result	Program	Problems noted
Apr 23, 2024	Problems found, fixed voluntarily	Drug Quality Assurance	5
Aug 27, 2019	Problems found, fixed voluntarily	Drug Quality Assurance	4
Nov 10, 2017	Problems found, fixed voluntarily	Drug Quality Assurance	—
Feb 12, 2016	No problems found	Drug Quality Assurance	—
Feb 3, 2015	No problems found	Drug Quality Assurance	—
Dec 13, 2012	Problems found, fixed voluntarily	Drug Quality Assurance	—
Jul 17, 2009	Problems found, fixed voluntarily	Bioresearch Monitoring	1
Jul 9, 2009	Problems found, fixed voluntarily	Drug Quality Assurance	—

From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.

Procedures for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed.
Environmental Monitoring System 21 CFR 211.42(c)(10)(iv)
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
Equipment to control conditions 21 CFR 211.42(c)(10)(vi)
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions.
Equipment Design, Size and Location 21 CFR 211.63
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use and cleaning and maintenance.
Written procedures not established/followed 21 CFR 211.67(b)
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.

Sterility/pyrogen-free testing 21 CFR 211.167(a)
Each batch of drug product purporting to be sterile is not laboratory tested to determine conformance to such requirements.
Identification of Persons Performing Significant Steps 21 CFR 211.188(b)(11)
The batch production and control records are deficient in that they do not include identification of persons supervising and checking each significant step in the operation.
Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review whether or not the batch has been already distributed.
Written control procedures 21 CFR 212.50(a)
You did not have written production and process control procedures to ensure and document that all key process parameters are controlled and any deviations from the procedures are justified.

Ensuring compliance with plan and protocol 21 CFR 312.50
Failure to ensure that an investigation was conducted in accordance with the general investigational plan and protocols as specified in the IND.

Registered with FDA for: analysis; api manufacture; label; manufacture; pack.