The Ministry of Food and Drug Safety announced on Nov. 29 that it will proceed with the revocation of the Good Manufacturing Practice (GMP) certification for large-scale dosage forms of solid oral preparations (tablets and capsules) of HUTECS Korea Pharmaceutical.
During an on-site inspection by the Ministry in July, HUTECS Korea Pharmaceutical was found to have falsified records, stating that six products, including Recutin Tablet, Roxacin Tablet, and Edi Tablet, were manufactured in accordance with authorized specifications, when in fact they were not.
The Ministry explained that this decision to revoke the GMP certification was made to eradicate intentional illegal manufacturing and falsification of pharmaceutical records.
Separately, for 64 products including Grulis Tablet 2 mg, which did not comply with GMP standards at the time, the Ministry decided to proceed with administrative penalties like the suspension of manufacturing operations.