Form 483 reveals spore contamination at a South Korean manufacturing site last year
An FDA inspection found several issues including spore-related contamination in the manufacturing area at a site in the city of Chuncheon, South Korea.
The inspection took place between Aug. 12 and Aug. 20 last year at the NO. 2 factory for Hugel, a maker of botulinum toxin(s), dermal fillers and other aesthetic products. The inspection itself found several major observations at the site in FDA documents that were disclosed on Tuesday.
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