1Other quality system
Input to and output from records or data are not checked for accuracy.
Inspection Record
Front Range Laboratories, Incorporated — FDA 483 Findings
Inspectors Nayan J Patel · Walden H LeeThe 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 and written.
3Laboratory and QC controls
The accuracy, specificity and reproducibility of test methods have not been established.
About this record
Extracted automatically from the document US FDA published on 2020-09-21. 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.
