1Laboratory and QC controls
Reserve samples from representative sample lots or batches ofdmg products selected by acceptable statistical procedures are not examinedvisually at least once a year for evidence ofdeterioration.
Inspection Record
Oishi Koseido Co., Ltd. — FDA 483 Findings
Inspectors Teresa I NavasThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
Input to and output from the computer andrecords or data are not checked for accuracy.
3Equipment and facility
Written records ofmajor equipment maintenance are not included in individual equipment logs.
4Material and supplier control
Labeling and packaging materials are not representatively sampledupon receipt and before use in packaging and labelingofa dmg product.
5Other quality system
Changes to written procedures are not drafted, reviewedand approved by the appropriate organizational unit.
6Stability and storage
There is no written testing program designed to assess the stability characteristics of drngproducts.
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.
