The QMN Weekly Bulletin
Pharmaceuticals / GMPs / Inspections and Audits

Baxter Hit With Form 483 Over Sterility Issues

Oct. 30, 2015

The FDA handed Baxter Healthcare a six-observation FDA Form 483 for lapses in sterile process controls and failure to review batch discrepancies at its Puerto Rico manufacturing plant.

Earlier this month, the company announced it was recalling 139,104 bags of 0.9 percent sodium chloride injection produced at the facility following complaints of mold on the interior surface of the overpouch — the firm’s ninth recall since December 2013.

The recalls come during a continued shortage of sodium chloride injection.

During the April 6 to May 1 inspection, the FDA investigator found that container closure systems didn’t protect against contamination or deterioration of the drug product, and the quality control unit didn’t ensure components and closures were safe and effective.

The form notes that between January and March, Baxter received complaints about missing or loose blue tip port protectors for IV solution products — a problem that has prompted eight recalls since December 2013.

The investigator also dinged Baxter for lacking procedures to ensure that routine laboratory activities are consistently evaluated by the quality unit and for not thoroughly investigating unexplained discrepancies and batch failures.

On four occasions, the quality control laboratory reported out-of-limit or out-of-specification results for the 0.9 percent sodium chloride injection product, which has been involved in almost every recent Baxter recall.

Further, control procedures for monitoring manufacturing processes had not been established. After receiving customer complaints about port issues and claiming to implement corrective actions, the issues still occurred, and investigations are in progress, the form says. The FDA listed similar observations following 2011 and 2014 inspections.

Finally, the facility failed to submit an NDA-Field Alert Report within three working days of receiving information regarding significant chemical, physical or other change or deterioration of a distributed drug product.

Baxter did not respond to a request for comment by press time.

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