483
Qilu Antibiotics Pharmaceutical Co. , Ltd.Qilu Antibiotics Pharmaceutical Co. , Ltd. – FDA 483, May 30, 2023
Record Details
Qilu Antibiotics Pharmaceutical Co., LTD. in Licheng District, Shandong, was inspected and found to have significant deficiencies in its manufacturing processes for sterile drug products. The inspection revealed failures in aseptic processing simulations, environmental control systems, laboratory controls, and quality unit training procedures, indicating a high severity of non-compliance with sterile manufacturing regulations.
View Company Profile
ID · ea74fdfa-9617-4364-b095-fabb92116823
Other documents for Qilu Antibiotics Pharmaceutical Co. , Ltd.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.