1Aseptic processing and sterility assurance
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic processing of d rug products.
Inspection Record
Triad Isotopes Inc. — FDA 483 Findings
Inspectors James G. FlahiveThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Laboratory and QC controls
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, qualily and purity.
3Training and personnel
Clothing of personnel engaged in the manufacturing, processing, packing, and holding of drug productS is not appropriate for the duties they perform.
4Quality unit oversight
The responsibilities and procedures applicable .to the quality control unit are not in writing and fully followed For example: A.You are not complying with your procedure No: 11.a.05.797, Version 3, effective 2/11/2014, in that signature approvals for verifying equip ment cleanin...
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.
