FDA 483 Finds Deficiencies at Baxter Healthcare Facility in Puerto Rico

FDA’s San Juan district office has found numerous problems at a Baxter sterile drug manufacturing facility in Jayuya, Puerto Rico following a series of inspections in late August through early October.

In Form 483 observations, the FDA investigators listed 10 deficiencies at the Baxter facility including a lack of written procedures for production and process controls, as well as other problems with records and the facility’s sanitation and general state of repair.

The firm received at least 94 consumer complaints regarding foreign matter inside sterile products, but it failed to conduct adequate visual inspections of finished drug products, the investigators found.