Samsung’s biologics plant in South Korea receives Form 483 over data integrity, other observations

FDA in­spec­tors un­cov­ered da­ta in­tegri­ty con­cerns with Sam­sung’s bi­o­log­ics plant, ac­cord­ing to a Form 483 re­leased this week fol­low­ing a 10-day agency in­spec­tion of the South Ko­rea-based site in Au­gust and Sep­tem­ber.

The Form 483 says that the site’s Man­u­fac­tur­ing Sci­en­tif­ic An­a­lyt­i­cal Tech­nol­o­gy (MSAT) lab­o­ra­to­ry (fea­tured here on Sam­sung’s web­site) had “in­ad­e­quate con­trols” over da­ta in­tegri­ty since 2013.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.