1Equipment and facility
Routine calibration of equipment is not performed according to a written program designed to assure proper performance.
Inspection Record
Delta Pharma Inc. — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Stability and storage
There is no written testing program designed to assess the stability characteristics of drug products.
3Material and supplier control
There is a failure to thoroughly review unexplained discrepancies 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.
4Labeling and packaging
The labels of your outsourcing facility's drug products do not include information required by section 503B(a)(10)(A).
5Aseptic processing and sterility assurance
Aseptic processing areas are deficient in that walls are not smooth and/or hard surfaces that are easily cleanable.
6Laboratory and QC controls
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications 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.
