Form 483 reveals spore contamination at a South Korean manufacturing site last year
07 Sep 2022
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.
The Form 483
noted that
clostridium botulinum
spores, which can
cause illness
, were present in the company’s drug substance manufacturing areas. The FDA noted that the area could not stop spore contamination risk to other manufacturing areas. The FDA also found that the site’s decontamination efforts were not adequate as the disinfectants used were not able to decontaminate the spores.
The Form 483 also noted that the spores were not a part of standard environmental monitoring at the site.
In addition, the FDA found an impurity with a particular product batch and found that more than 12 logbooks went missing after several years. A working cell bank that is used to manufacture drugs was found to be mixed up with another working cell bank.
A batch failure was also noted by the FDA with damaged vials and operators taking breaks being major causes.
Hugel joins several manufacturers in Korea that have hit regulatory walls in the past year. Last year, Samsung Pharmaceutical’s manufacturing operations
had to be suspended
after South Korea’s health regulator found that a production manager was tasked with responsibilities for two different plants, which violated a law requiring each plant to be managed by one person. This led to six drugs being halted from being produced for several months.
In April of this year, Vivozon
had to halt drug production
and was ordered to recall and discard 13 drugs after violating good manufacturing practice standards.
Other companies such as Celltrion and Daewoong Pharmaceutical have also received observations from the FDA since 2017.
For more details,please visit the original website
The content of the article does not represent any opinions of Synapse and its affiliated companies. If there is any copyright infringement or error, please contact us, and we will deal with it within 24 hours.
Indications
-Targets
-Hot reports
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Leverages most recent intelligence information, enabling fullest potential.