FDA 483 - Qilu Antibiotics Pharmaceutical Co. , Ltd. - April 26, 2021
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An FDA inspection of QILU ANTIBIOTICS PHARMACEUTICAL CO. LTD identified significant deficiencies in aseptic processing, including inadequate fumigation validation and unapproved cleaning procedures for Grade A areas. The firm also failed to follow procedures for preventing microbiological contamination, as evidenced by defective sterile drug product vials not being rejected during visual inspection. Additionally, equipment cleaning and use logs lacked proper two-person verification, indicating a breakdown in documentation practices.
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