The recent disclosure of the 'FORM 483' report by the U.S. Food and Drug Administration (FDA) pertaining to Samsung Biologics has garnered significant attention not only in South Korea but also on the international stage, offering insights into the origins and significance of this development. Remarkably, it has come to light that a highly unusual number of FDA investigators were engaged in scrutinizing Samsung Biologics.

According to the FORM 483 issued to Samsung Biologics on September 1st, the FDA inspection team was composed of five individuals. In the industry, this number holds substantial significance.

Official records of FORM 483 issuances from 2022 to 2023, publicly available on the FDA's website, account for a total of 44 cases. Excluding Samsung Biologics, the highest number of investigators deployed for inspections was four. The FDA's own data reveals that, over the past two years, Samsung Biologics is the sole company to have undergone an inspection with five investigators.

In these 44 instances of FORM 483 issuance, the average number of investigators participating in inspections stands at 2.5. Samsung Biologics, having twice the standard number of FDA investigators, marks an exceptional scenario. Notably, respected companies like UCB, Wuxi, and Catalent underwent inspections with 1, 1, and 3 investigators, respectively, suggesting that the number of FDA investigators engaged in inspections does not seem to correlate significantly with the size of the companies in question.

Commenting on this, an industry insider observed, "The presence of five FDA investigators during the approximately 10-day inspection of Samsung Biologics is highly unusual." They further remarked, "Typically, inspections involve around three investigators, and having five scrutinize Samsung Biologics for ten days indicates a matter of significant concern that warranted this level of attention."

Meanwhile, it is worth noting that Samsung Biologics has accumulated a total of 10 FORM 483 reports since 2016. The latest FORM 483 was officially disclosed on the FDA's website on October 17th, listing six issues, including improper data integrity management, delays in device revalidation, and inadequate facility oversight. Some industry experts even view these problems as potential violations of fundamental GMP principles.

In response, Samsung Biologics has stated their official position, asserting, "Receiving FORM 483 does not signify any serious deficiencies in our processes or issues that cannot be resolved." A company spokesperson emphasized, "It is crucial to understand that the receipt of FORM 483 does not impact product quality or patient safety in any way."