The Ministry of Food and Drug Safety imposed a three-month manufacturing suspension on two nutritional injection products of Samsung Pharm, GC Wellbeing Amino Inj. And GC WellBbing Neuramin Inc., last Thursday.

The reason for the disposition is the “violation of the regulations on management responsibility for the trustee.” The ministry said that GC Wellbeing failed to thoroughly manage and supervise Samsung Pharm, entrusted to manufacture these items. The disposition period is from Sept. 23 to Dec. 22.

According to the ministry, in manufacturing the two items, Samsung Pharm did not calculate the results of the acetylcysteine content test according to the reported criteria and method and judged its appropriateness using an arbitrary result calculation method.

As a result, Samsung Pharm violated the Pharmaceutical Affairs Act by not changing management although changes occurred in reported items, it added.

Last December, GC Wellbeing Amino Inj. and GC Wellbeing Neuramin Inj. Put their names on the list of retrieval and disposal. The reason: preventive steps due to concerns about inadequacy in the content test.

In the case of GC Wellbeing Amino Inj., some manufacturing number products made between 2019 and 2021, and in the case of GC Wellbeing Neuramin Inj., some products made in 2020 were subject to retrieval and disposal.

Meanwhile, GC Wellbeing completed the construction of its plants to manufacture injection products in Eumsong, North Chungcheong Province, in June last year. The company said at the time that it would secure manufacturing competitiveness by increasing the in-house production of nutritional injections in keeping with their continuous sales increase.