Sam Chun Dang Pharm(000250) violated pharmaceutical manufacturing and management standards and failed to properly carry out oversight and recall procedures for some items, receiving an administrative disposition from the Ministery of Food and Drug Safety.
According to the Ministery of Food and Drug Safety on the 24th, Sam Chun Dang Pharm was given a 15-day suspension of operations for manufacturing nasal drops (nasal spray) for failing to comply with the manufacturing control standards manual. The suspension runs from on the 21st to Aug. 4.
Drug manufacturing contractors must prepare product-specific manufacturing control and quality control manuals and conduct manufacturing and quality control accordingly, but Sam Chun Dang Pharm was found not to have followed the contents of the manufacturing control standards manual.
Leprojin syrup (levodropropizine) also received a suspension of manufacturing operations for 3 months and 7 days. The suspension runs from on the 21st to Oct. 27.
The Ministery of Food and Drug Safety said Sam Chun Dang Pharm did not properly supervise the manufacturing control of the contractor entrusted with producing Leprojin syrup. It also said that even after recognizing issues with the stability and efficacy of Leprojin syrup (batch No. 24011), the company failed to submit a recall plan within the statutory five-day deadline, and submitting the recall plan late without requesting an extension of the deadline was also included as grounds for the disposition.