1Other quality system
Records associated with drug product production and within the retention period for such records, were not made readily available for authorized inspection.
Inspection Record
Jiangsu Hengrui Pharmceuticals Co., Ltd — FDA 483 Findings
Inspectors Arsen KarapetyanThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Quality unit oversight
The quality control unit lacks responsibility to approve all procedures or specifications impacting on the identity, strength, quality and purity ofdrug products.
3Other quality system
Economic and Technological Dev Zone TYPE ESTABLISHMENT INSPECTED Finished Dru Manufacturer Bui Idings used in the holding ofa drug product are not maintained in a good state of repair.
4Computer system validation
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only bv authorized personnel.
5Contamination control
Container closure systems do not provide adequate protection against foreseeable external factors in storage and use that can cause deterioration or contamination of the drug product.
6Equipment and facility
Equipment and utensils are not cleaned appropriately to prevent contamination that would alter the safety, identity, strength, quality or purity ofthe drug product.
7Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did nol include adequate validation ofthe aseptic and sterilization process.
8Equipment and facility
Washing and toilet facilities lack hot and cold water.
About this record
Extracted automatically from the document US FDA published on 2024-06-04. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
