1Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
Inspection Record
IntegraDose Compounding Services LLC — FDA 483 Findings
Inspectors Anthony J Ladner · Ross J Grigsby · Kevin P ReganThe 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
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed.
3Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
4Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions.
About this record
Extracted automatically from the document US FDA published on 2021-10-28. 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.
