1Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include validation of the sterilization process.
Inspection Record
RXQ Compounding 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 is not laboratory tested to determine conformance to such requirements.
3Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
4Labeling and packaging
The labels and containers of your outsourcing facility's drug products do not include information required by section 503B(a)(10)(A) and (B).
5Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
6Documentation and records
The batch production and control records are deficient in that they do not include copy of labeling.
7Documentation and records
Batch production and control records do not include a description of drug product containers and closures used for each batch of drug product produced.
8Training and personnel
Clothing of personnel engaged in the manufacturing of drug products is not appropriate for the duties they perform.
9Aseptic processing and sterility assurance
Test procedures relative to appropriate laboratory testing for s terility are not followed.
10Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure.
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.
