1Other quality system
Test devices are deficient in that instruments not meeting established specifications are used.
Inspection Record
IntegraDose Compounding Services LLC — FDA 483 Findings
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 systems for maintaining any equipment used to control the aseptic conditions.
3Material and supplier control
There is a failure to thoroughly review the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
4Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed.
5Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
6Equipment and facility
There is a lack of written procedm es describing in sufficient detail the methods, equipment and materials to be used for sanitation.
About this record
Extracted automatically from the document US FDA published on 2019-04-30. 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.
