Overview:

The United States Food and Drug Administration lifts halt on domestic routine surveillance facility inspections starting July 20, 2020.

The decision was made after 2 months of the agency’s approach to phase implementation of restarting surveillance and 4 months after the holding all domestic surveillance programs.

FDA will resume domestic inspections

FDA has increased its efforts over the last few months to regulate the industry by remote assessments, import alerts and other compliance requirements and is taking a step-forward in the phase approach by resuming on-site domestic inspection, FDA will take all the precautionary measures to minimize risk of spreading the virus with help protect staff with all outfitting personal protective equipment as per the CDC (Center for Disease Control) guidance.

Inspections will vary by State

The inspection sites will vary and depend on the virus trajectory in each state and will follow all the guidelines set forth by the local and state governments while announcing inspections. The FDA will announce and prioritize inspections using a new risk assessment system to learn the state and country level risk posed by the virus. While announcing inspections to firms, FDA will rely and follow all the guidelines set forward by CDC and White house to mitigate risk and protect its staff from the exposure.

About Global Regulatory Partners

Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations.  To learn more, please contact us at  info@globalregulatorypartners.com

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