1Contamination control
Protective apparel is not worn as necessary to protect drug products from contamination.
Inspection Record
Front Range Laboratories, Incorporated — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Training and personnel
Employees engaged in the manufacture, processing, packing, and holding ofa drug product lack the education, training, and experience required to perfotm their assigned functions.
3Laboratory and QC controls
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
4Quality unit oversight
There is no quality control unit.
5Laboratory and QC controls
The written stability program for drug products does not include reliable, meaningful, and specific test methods.
About this record
Extracted automatically from the document US FDA published on 2024-01-17. 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.
