Final Guidance: FDA Has 45 Days To Give Feedback On Solutions To Form-483 Observations
The US agency will provide nonbinding feedback to qualifying manufacturers on possible remedies to particularly egregious observations noted by agency investigators on FDA-483 inspection forms, says a guidance doc released on 21 April.
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FDA Draft Guidance Outlines Agency's Plan To Offer Nonbinding Feedback On Form-483 Observation Resolutions
Device manufacturers would be able to get nonbinding feedback on their plans for how to resolve some Form-483 inspectional observations from US FDA officials under a new draft guidance released Feb. 15.
Medical device manufacturers initiated fewer recalls in the third quarter of 2020. Check out our Q3 recalls infographic.
The coming pilot program would give the US FDA remote access to a manufacturer’s records. It’s another approach the agency wants to try as it feels out the best way to virtually evaluate regulatory compliance during the COVID-19 pandemic.