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WWL051419

Week of May 5th, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

Enforcement was light this week, including a single warning letter to a drug manufacturer in France.  Laboratoires Clarins (Pontoise, France) received a warning letter on April 23, 2019 based on the outcome of an inspection ending September 21, 2018.  FDA points the firm to the FDA guidance on the investigation of OOS events and process validation guidance.  In addition, they recommend the firm hire qualified consultants to assist them in coming into compliance.

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New FDA Website Launched This Week

Have you clicked over to the FDA website recently? If so, you saw that the site has a whole new look and feel. After three years in the works, the US Food and Drug Administration (FDA) launched a more customer-centric website at FDA.gov that’s easier to search and view on all browser types and sizes. One thing to note is you may find old links to the site no longer work, “Most URLs will change. Automatic redirects will be established, but users should update their bookmarks,” the FDA spokesperson said. What does this mean for users of the FDAzilla platform and blog?

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FDA Form 483s - April

April 2019 | New FDA 483s

In April of 2019, we added 226 483s to our database of 27,500+ FDA inspection documents. (NOTE: Are you interested in learning more about observations with specific industry keywords? Get your FREE 483 Observation Report and you can quickly determine who has been hit with the same observations. Learn more here!)

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