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
Unico Holdings, Inc. — FDA 483 Findings
Inspectors German RiveraThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
Routine calibration, inspection, and checking of automatic and mechanical equipment is not performed according to a written program designed to assure proper performance.
3Contamination control
All reasonable precautions are not taken to ensure that production procedures do not contribute contamination from any source.
About this record
Extracted automatically from the document US FDA published on 2024-01-17. 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.
