1Equipment and facility
Routine calibration of equipment is not performed according to a written program designed to assure proper performance.
Inspection Record
RC Outsourcing LLC — FDA 483 Findings
Inspectors Joshua P WiremanThe 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
Each batch of drug product purporting to be sterile and pyrogen-free is not laboratory tested to de termine conform ance to such requirements.
3Complaint and recall handling
Complaint files are not maintained.
4Other quality system
DEP ART!\fi:NT OF HEALTH AND HUMAi'l SERVICES DISTRICT ADDRESS AND PHONE NUMBER ive l /25/2016- 2/9/2016* Cincinnat i, OH 45237- 3097 FEJNUMBER (513)679- 2700 Fax : (513)679- 2772 3011967886 NAME AND TITLE OF INDM OUAL TO WHOM REPORT ISSUED Raymond R.
5Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
6Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to b e steril e are not followed.
7Labeling and packaging
The labels of your outsourcing facility’s drug products are deficient.
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.
