January is a time when all facilities should revisit their quality strategy, and adjust it for the new year. Part of a good strategy is learning from mistakes in the past, and shifting priorities accordingly. Understanding previous FDA inspection observations can help you improve your facilities’ quality strategy.
Today, we are releasing our Annual Report that highlights the most frequently cited FDA Inspection Observations of Fiscal Year 2022, preparing our subscribers for FDA inspections in 2023.
Notable observations from the report:
- FDA’s inspections over the 2022 fiscal year increased from the prior year, but are still not up to levels seen prior to the pandemic. Visit FDA’s Data Dashboard for full statistics on FDA Inspections in 2022.
- Top cited observations for Drug facilities remains mostly the same, with few changes to the top 5.
- The most frequently cited observations for Device facilities has changed.
The information about these observations found in our Annual Report will give you valuable information to use when forming your quality strategy for 2023.
The team at GMP Trends would like to thank you for your commitment to quality and safety. We value your efforts and readership.
We are here to assist your regulatory procedures to best prepare for an FDA inspection in 2023.
Visit our Store and plan your 2023 quality strategy today.