Day: May 14, 2019


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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