1Labeling and packaging
The labels for the drug products and drug product containers you produce do not contain information required by section 503B(a)(l0).
Inspection Record
Edge Pharmacy Sevices, LLC — FDA 483 Findings
Inspectors Edmund F. Mrak Jr.The inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
3Material and supplier control
Each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.
4Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile do not include adequate validation ofthe sterilization process.
5Laboratory and QC controls
Testing and release ofdrug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the identity and strength ofeach active ingredient prior to release.
6Aseptic processing and sterility assurance
Each batch of drug product purporting to be sterile is not laboratory tested to determine conformance to such requirements.
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.
