1Labeling and packaging
Neither the label nor the container of your outsourcing falcility's Phenylephrine 100 mcg per mL, 5 mL syringe dr ug product includes the following.
Inspection Record
Resource Optimization & Innovation LLC — FDA 483 Findings
Inspectors Michele Perry-WilliamsThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Material and supplier control
There is a failure to thoroughly review 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.
3Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditioos.
4Documentation 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 manufacturing and processing.
5Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established or followed: Specifically, A.
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.
