Terumo 483 Details Shortfalls on Environmental Controls

Terumo BCT has received a Form 483 citing manufacturing problems with incoming product acceptance and environmental controls on its blood collection systems.

The company’s receiving procedure did not ensure inspection and verification, with documented results, for products used to make Trima automated blood collection systems, according to the May 20 form, recently released. While the procedure required an incoming inspection for some products, it was not conducted for certain lots, it added.

The form also noted issues related to environmental controls. For example, the microbial air sampling procedure did not set the testing frequency for each site location.

For cleanroom air sampling, Terumo had established alert and action levels based on a review of historical data from air sampling. However, it did not reevaluate alert and action levels when it changed its air sample volumes, the form says.

Meanwhile, the bioburden procedure does not ensure that changes to the method of determining bioburden are assessed for their impact. “Your firm provided a list of changes made to the bioburden method since 1996; however, this list was provided upon our request and shows your firm did not evaluate the changes as they were implemented,” the form says.

Terumo received 311 customer complaints between Feb. 3, 2012, and May 1 for issues it attributed to user errors during the setup of blood collection or apheresis systems. For 12 of those complaints reviewed during the inspection, the company had concluded no corrective action was required. “Your firm did not consider user training (or re-training) as a potential corrective action,” according to the form.

Terumo did not respond to a request for comment by press time. The Form 483 is available at www.fdanews.com/09-29-14-Terumo.pdf.