1Training and personnel
Employees engaged in the manufacture and processing of a drug product lack the training required to perform their assigned functions.
Inspection Record
IntegraDose Compounding Services LLC — FDA 483 Findings
Inspectors Logan T WilliamsThe 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
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions.
3Laboratory and QC controls
The statistical quality control criteria fail to include appropriate rejection levels.
4Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not written and followed.
5Quality unit oversight
The quality control unit lacks responsibility to approve all procedures or specifications impacting on the identity, strength, quality and purity of drug products.
About this record
Extracted automatically from the document US FDA published on 2025-08-28. 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.
