1Equipment and facility
Equipment for adequate control over air pressure and micro-organisms is not provided when appropriate f or the manufacture, processing, packing or holding of a drug product.
Inspection Record
Edge Pharmacy Services, LLC — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Quality unit oversight
Drug product production and control records, are not reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed.
3Contamination control
Separate or defined areas to prevent contamination or mix-ups are deficient regarding the manufacturing and processing operations .
4Aseptic processing and sterility assurance
Test procedures relative to appropriate laboratory testing for pyrogens are not written and followed.
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.
