1Equipment and facility
Buildings used in the manufacturing and processing of a dmg product are not maintained in a good state of repair.
Inspection Record
Trone Health Services, 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 dmg products.
3Aseptic processing and sterility assurance
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic processing of drug products.
4Laboratory and QC controls
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications and identity and strength of each active ingredient prior to release.
5Other quality system
Control procedures fail to include adequacy of mixing to assure uniformity and homogeneity.
6Deviation, CAPA, and investigation
Written records are not made of investigations into unexplained discrepancies and the failure of a batch or any of its components to meet specifications.
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.
