1Laboratory and QC controls
Supervisory oversight over the laboratory electronic systems and data is deficient.
Inspection Record
Yuki Gosei Kogyo Co. Ltd. — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Material and supplier control
Each lot in shipment received was not identified with a distinctive code for each container or grouping of containers for components.
3Quality unit oversight
The Quality Unit lacks adequate control of expired laboratory reagents, samples to be tested and finished batches.
4Equipment and facility
Equipment used in the manufacture or holding of drug components is not of appropriate design to facilitate | operations for its intended use and maintenance.
5Other quality system
Records associated with drug substance production and within the retention period for such records, were not made readily available for authorized inspection.
6Laboratory and QC controls
Equipment used during laboratory operations and production of an intermediate or API are not appropriately } identified.
7Quality unit oversight
Document control of laboratory testing records by the Quality Unit is inadequate.
About this record
Extracted automatically from the document US FDA published on 2018-09-10. 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.
