The FDA has laid out some new, temporary policy changes to prevent the spread of COVID-19. These updated policies are part of their “good guidance practices.” These policies are especially important to implement quickly, as COVID-19 is spreading quickly. The FDA wants to curb the spread as quickly as they can.
The old guidelines include the need for an “onsite audit” in warehouses. These audits are necessary to maintain cleanliness standards and to also prevent COVID-19 from spreading even more. Consequently, the FDA acknowledged that some traditional audits were no longer possible.
Suppliers cannot necessarily travel to impacted countries anymore. In this case, an onsite audit of those supply chains is impossible. Rather, the FDA stated in their guidance that they would not be enforcing some regulations. There are only four circumstances the FDA will not enforce.
These FDA policies would include the following:
The FDA understands that traveling to foreign countries where products may be made is not necessarily possible at this moment. Therefore, those suppliers should choose an alternate way of monitoring their own products. It is important to note, however, that these exemptions only apply to facilities where travel advisories are in place.
The FDA also noted that these facilities should continue their audits “within a reasonable period of time” whenever they are able to. Importers and receiving facilities should still maintain their levels of cleanliness as usual.
Where American Medical Compliance can help:
These are unprecedented times, and American Medical Compliance is here to help. We have an updated course on new guidelines they plan to roll out so your organization is up to date on compliance laws. These times are confusing, which is why it is necessary to have an easy-to-follow program designed for your benefit.
To learn more about what we offer, visit our website:
https://americanmedicalcompliance.com/
And to read the guidelines, click here:
