Samsung BioLogics Cited for Issues with HEPA Filters

A facility owned by Samsung BioLogics in Korea was cited in a Form 483 after FDA inspectors found problems with its air filtration system.

The inspection revealed integrity problems with high-efficiency particulate arrestance (HEPA) filters in the restricted-access filling line for Samsung’s drug products.

On two separate occasions leaks were detected in HEPA filters and air flow machines that impacted batches of Samsung’s drug product.