1Laboratory and QC controls
Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures are not examined visually at least once a year for evidence of deterioration.
Inspection Record
Nephron Pharmaceuticals — FDA 483 Findings
Inspectors Logan T Williams · Robert J HamThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Stability and storage
Drug products are not stored under appropriate conditions of humidity and light so that their identity, strength, quality, and purity are not affected.
3Training and personnel
Employees are not given training in written procedures required by current good manufacturing practice regulations.
4Quality unit oversight
There is no quality control unit.
About this record
Extracted automatically from the document US FDA published on 2023-05-16. 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.
