1Equipment and facility
Buildings used in the manufacture, processing, packing, or holding of a drug product do not have the suitable construction to facilitate cleaning, maintenance, and proper operations.
Inspection Record
RC Outsourcing LLC — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Labeling and packaging
The labels of your outsourcing facility’s drug products are deficient.
3Complaint and recall handling
Complaint files are not maintained.
4Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
5Aseptic processing and sterility assurance
Each batch of drug product purporting to be sterile and pyrogen-free is not laboratory tested to determine conformance to such requirements.
6Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed.
7Equipment and facility
Routine calibration of equipment is not performed according to a written program designed to assure proper performance.
8Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental condi tions.
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.
