1Other quality system
Employees engaged in the processing of a diug product lack the ti·aining required to perfo1m their assigned functions.
Inspection Record
Hanlim Pharm Co., Ltd. — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Laboratory and QC controls
Established test procedures are not documented at the time of perfo1mance.
3Aseptic processing and sterility assurance
Procedmes designed to prevent microbiological contamination of diug products pmpo1ting to be sterile do not include adequate validation of the sterilization process.
4Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
5Aseptic processing and sterility assurance
Procedmes designed to prevent microbiological contamination of diug products pmpo1ting to be sterile are not followed.
6Laboratory and QC controls
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications designed to assure that diug products confo1m to appropriate standards of identity, strength, quality and purity.
About this record
Extracted automatically from the document US FDA published on 2025-03-06. 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.
