1Material and supplier control
Representative samples are not taken of each shipment of each lot of components for testing or examination .
Inspection Record
Delta Pharma, Inc. — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Process validation
Written procedures are not established that describe the in-process controls, tests and examinations to be conducted on appropriate samples of in-process materials of each batch.
3Material and supplier control
Written procedures are not followed for the sampling and testing of components.
About this record
Extracted automatically from the document US FDA published on 2024-05-21. 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.
