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The QMN Weekly Bulletin

FDA Hits Fusion IV for Incomplete Labeling, Environmental Monitoring

Aug. 11, 2017

The FDA cited Fusion IV Pharmaceuticals for incomplete labels and failing to properly monitor environmental conditions.

The agency issued a Form 483 following a March inspection of the company’s Los Angeles facility. Investigators said the company omitted information from several of its drugs’ labels. The labels for 15 sterile drug products produced by the outsourcing facility, including its injectables for testosterone cypionate, ascorbic acid, gluthathione and human chorionic gonadotropin, did not contain the required statement “office use only.”

Investigators found the company did not properly monitor laminar air flow work stations in the filling room for potential microbiological air and surface contamination for lots categorized as “not a batch.”

The agency took the company to task for its procedures to prevent microbiological contamination. The company failed to complete method suitability testing for some of its products, and never performed an effectiveness study to validate its preservative system.

The company also failed to sterilize and process its drug containers to confirm suitability and removal of pyrogenic properties, and records on incubation of other products were missing key information.

Lastly, the investigators found the company did not conduct investigations into media fill sterility failures, and did not submit the initial required report to the agency identifying products compounded over the last six months.

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