Two Baxter Healthcare manufacturing plants in Puerto Rico ran afoul of the FDA over defect reporting. The warning encompasses the anesthetic Suprane in addition to amino acid and critical care products.
Baxter failed to file NDA field alert reports (FARs) when it became aware of product defects, according to Warning Letter 11-SJN-WL-04. Regulations require the reports to be filed within three working days.
"Since February 2010, your Jayuya facility has received approximately 43 incidences of consumer complaints related to discoloration in your product," the warning letter states. "Although an internal investigation confirmed a correlation between [a] broken damper and the discolored amino acid samples solutions, no FAR was submitted."
The situation at the Guayama facility was similar. Complaints describing discoloration and particle contamination stretched back to 2004 and numbered nearly 200, according to the warning letter. No FAR was submitted.
The Baxter investigation concluded that healthcare professionals would spot the discoloration and not use the product. "It is unacceptable to rely upon the healthcare professional to fulfill your Quality Control Unit responsibilities."