FDA Hits Baxter with Form 483 Over Lapses in Sterile Process Controls

September 2, 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. The drugmaker has been plagued in recent months over recalls of sterile IV solutions.

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 that the quality control unit didn’t ensure components and closures were safe and effective, the form says.

The form also 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, three of them this year.

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 between September and October 2014, the quality control laboratory reported out-of-limit or out-of-specification results for a 0.9 percent sodium chloride injection — a product that has been involved in almost every recent Baxter recall.

Further, control procedures for monitor 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. View the Form 483 at www.fdanews.com/08-28-15-Baxter483.pdf. — Kellen Owings