1Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
Inspection Record
ProRx LLC — FDA 483 Findings
Inspectors Taichun QinThe 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 drng products purporting to be sterile are not established, written and followed.
3Deviation, 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 ah-eady distributed.
4Labeling and packaging
The labels ofyour outsourcing facility's drng products do not include infonnation required by section 503B(a)(10)(A) of the Federal Food, Drng, and Cosmetic Act (FD&C Act).
5Laboratory and QC controls
The quality control tmit lacks responsibility to approve and reject all procedures or specifications impacting on the quality of drug products.
6Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drng products purporting to be sterile did not include adequate validation ofthe aseptic and sterilization process.
7Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
About this record
Extracted automatically from the document US FDA published on 2025-12-15. 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.
