Inspection Record

Front Range Laboratories, Incorporated — FDA 483 Findings

US FDAInspected 2020-03-20Published 2020-09-21 3 findingsOther quality systemAseptic processing and sterility assuranceLaboratory and QC controls

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

1Other quality system

Input to and output from records or data are not checked for accuracy.

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.

Other records for this company

2015-07-11 · US FDA · 5 findings
Front Range Laboratories, Incorporated company profile — full history US FDA documents, 2020 Go to Findings search