Reduce the Risk of 483 Observations

February 1, 2018, Lakewood, Colorado – Each new year presents the potential for inspections of FDA 503b regulated outsourcing facilities, and with them, the possibility that 483 observations could be issued. 483 Forms are issued to a facility when the FDA inspector has observed any condition that may constitute a violation of the Food Drug…

Designing a Temperature Mapping Layout

Lakewood, Colorado, August 1, 2017 – When planning a temperature mapping you should always start by reviewing the layout of the area that is going to be mapped. The purpose of performing the temperature mappings is to verify that the conditions that your critical products are being stored at are the correct conditions and if…