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

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

By |2019-05-14T10:05:16-05:00May 14th, 2019|Biopharma / Pharma, CGMP, FDA, FDA Warning Letters, FDAzilla|

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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About the Author

Barbara W. Unger

Barbara W. Unger is Govzilla’s Quality Expert and Editor-in-Chief of GMP Regulatory Intelligence. She formed Unger Consulting, Inc. in December 2014 to provide GMP Quality consulting services to the pharmaceutical and biopharmaceutical industry. At Amgen, she led the segment of the Corporate GMP Audit group at Amgen focused on API manufacturers, Quality Systems and Computers. She developed, implemented and maintained the GMP Regulatory Intelligence program for 8 years at Amgen Inc. This included surveillance, analysis and communication of GMP related legislation, regulations, guidance and industry compliance enforcement trends. This was an essential service and tool within the Corporate Audit function.

Unger Consulting Inc. | www.ungerconsulting.net | 805.217.9360

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