1Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
Inspection Record
Laboratorios Farmaceuticos Rovi S. A. — FDA 483 Findings
Inspectors Arsen KarapetyanThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of diug products pmpo1t ing to be sterile are not followed.
3Equipment and facility
Equipment used in the manufacture, processing, packing or holding of diug products is not of appropriate design to facilitate operations for its intended use.
4Deviation, CAPA, and investigation
Written records of investigations into unexplained discrepancies and the failure ofa batch or any of its components to meet specifications do not always include the conclusions and follow-up.
About this record
Extracted automatically from the document US FDA published on 2024-09-17. 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.
