1Material and supplier control
Separate or defined areas to prevent contamination are deficient regarding operations related to the storage of raw materials and finished APJ products.
Inspection Record
Shouguang Fukang Pharmaceutical Co., Ltd. — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
Analytical methods are not suitable for their intended use and/or have not been established.
3Quality unit oversight
The quality control unit lacks responsibility to approve fi nal testing results for product release.
4Equipment and facility
Equipment is not cleaned or maintained at appropriate intervals to prevent contamination that would alter the quality or purity ofthe APl product.
5Aseptic processing and sterility assurance
Failure to perform proper aseptic techniques during microbial testing ofproducts.
6Equipment and facility
Adequate lighting is not provided in all areas.
7Process validation
Time limits are not established for the completion ofeach production phase to assure the quality ofthe drug product.
8Other quality system
Samples taken ofproducts for determination ofconformance to written specifications are not properly released to the QC department of testing.
About this record
Extracted automatically from the document US FDA published on 2026-05-06. 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.
