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FDA Registration Renewal timelines – when to renew your FDA registration. September 11, 2020

  Generally, FDA registration renewal timelines are from October 1 to December 31 every year. However, the annual registration requirement may vary based on the product category. Summary of FDA registration renewal requirements.     Food facility registration renewal timelines   Food facilities registration is required every even year between the 1st of October and … Continue reading FDA Registration Renewal timelines – when to renew your FDA registration. .... Read More

How to avoid FDA recall action for hand sanitizer and comply with FDA regulations for hand sanitizer September 7, 2020

In this article,  you will understand how to avoid FDA recall action for hand sanitizer and comply with FDA regulations for hand sanitizer. This article will be helpful for companies manufacturing and importing hand sanitizer into the USA.   Even though hand sanitizer containing OTC ingredients (Alcohol and benzalkonium chloride) does not require prior approval … Continue reading How to avoid FDA recall action for hand sanitizer and comply with FDA regulations for hand sanitizer .... Read More

FDA establishment registration fee FY 2021 August 12, 2020

FDA registration fee FY 2021 FDA has published the annual establishment registration fee for FY 2021, which will be effective from October 1, 2020. The FDA registration fee for each medical device establishment is $5,546. All medical device establishments intended to register/renew their facility are required to pay the establishment registration fee. Waivers or reductions … Continue reading FDA establishment registration fee FY 2021 .... Read More

Understanding FDA temporary policy for Hand sanitizer -Updated 15th April 2020 April 22, 2020

Understanding Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) Guidance for Industry   To prepare hand sanitizer as per the FDA’s temporary policy, you should consider compliance with the below requirements.   Because of the public health emergency posed by COVID-19, FDA does not intend to take … Continue reading Understanding FDA temporary policy for Hand sanitizer -Updated 15th April 2020 .... Read More

FDA has published Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products March 14, 2020

Summary of  FDA guidance for alcohol based hand sanitizers (temporary policy)   FDA has published Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products . Here is the summary of FDA’s temporary policy for hand sanitizers. Because of the public health emergency posed by COVID-19, FDA does not intend to take action against compounders … Continue reading FDA has published Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products .... Read More

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