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 and Cosmetic (FD&C) Act.
With each inspection, it is critical that the facilities and equipment used in the compounding of drug products can meet FDA, United States Pharmacopeia (USP), or International Organization for Standardization (ISO) requirements.
To meet these stringent requirements, clean rooms should be validated with environmental monitoring, and sterilization equipment such as sterilizing filters, depyrogenation ovens, and autoclaves should also be validated. Product storage areas such as warehouses, refrigerators, incubators, and freezers may also be validated to reduce the potential for 483 observations.
Any equipment or space used for the compounding of products should be validated.
Contact Mesa Laboratories, Inc. today to see how we can help.