1Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed.
Inspection Record
Qualgen LLC — FDA 483 Findings
Inspectors Logan T Williams · Zachary L StammThe 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 specifications and sampling plans designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
3Quality unit oversight
The quality control unit lacks responsibility to reject all procedures or specifications impacting on the identity, strength, quality and purity of drug products.
4Contamination control
There is insufficient physical or spatial separation from operations and other drug products to prevent mix-ups and cross-contamination.
5Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
About this record
Extracted automatically from the document US FDA published on 2026-01-16. 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.
