1Regulatory reporting and change control
Your outsourcing facility has not submitted a report to FDA identifying all products compounded during the previous six month period as required by section 503B(b)(2)(A).
Inspection Record
Pine Pharmaceuticals — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Labeling 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).
3Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions .
4Material 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.
5Laboratory and QC controls
For each batch of drug product, there shall be appropriate laboratory determination of satisfactory conformance to final specifications for the drug product,including the identity and strength of each active ingredient, prior to release.
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.
