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.  We cover it below.

 

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DRUG | Laboratoires Clarins

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.

Deficiencies include but are not limited to:

  • The firm did not adequately investigate OOS event for critical product attributes including assay.  Also, no corrective actions were put in place to prevent their recurrence.
  • The firm failed to qualify equipment, validate processes and establish an ongoing process monitoring program.
  • The firm has not adequately validated that equipment cleaning and disinfection is adequate to remove potential contaminants.  Cleaning evaluation is limited to a visual inspection.

 

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