Category: FDA

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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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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