1Training and personnel
Clothing of personnel engaged in the manufacturing, processing, packing, and holding of drug products is not appropriate for t he duties they perform.
Inspection Record
Triad Isotopes Inc. — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Quality unit oversight
The responsibilities aod procedures applicable to the quality contro l unit are not in writing and fully followed.
3Aseptic processing and sterility assurance
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to asep tic processing of drug products.
4Laboratory and QC controls
Laboratory controls do n ot include the establishment of scientifically sound and appropriate test procedures designed to ass ure that drug products conform tO appropriate standards of identity, strength, quality and purity.
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.
