1Validation and qualification
The number of qualified personnel is inadequate to supervise the manufacture, processing, packing and holding of each drug product.
Inspection Record
RXQ Compounding LLC — FDA 483 Findings
Inspectors Lindsey M SchwierjohannThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Process validation
Written production and process control procedures are not followed in the execution of production and process control functions and documented at the time of performance.
3Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not written and followed.
4Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
5Laboratory and QC controls
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the identity and strength of each active ingredient prior to release.
6Process validation
Time limits are not established when appropriate for the completion of each production phase to assure the quality of the drug product.
7Aseptic processing and sterility assurance
Aseptic processing areac; are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
8Documentation and records
The batch production and control records are deficient in that they do not include documentation of the accomplishment of each significant step in processing.
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.
