www.fdanews.com/articles/179151-samsung-biologics-cited-for-issues-with-hepa-filters
Samsung BioLogics Cited for Issues with HEPA Filters
November 4, 2016
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.