1Labeling and packaging
The container of your outsourcing facility's drug products does not include information required b y section 503B(a)(10)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Inspection Record
OSRX Inc. — FDA 483 Findings
Inspectors Jazmine N BrownThe 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 determine conformance to such requirements.
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 already distributed.
4Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
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 diug products purporting to be sterile are not established and followed.
About this record
Extracted automatically from the document US FDA published on 2024-11-21. 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.
