Week of November 4th 2018 | FDA Sent These Warning Letters to Pharma Companies

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Week of November 4th 2018 | FDA Sent These Warning Letters to Pharma Companies

This was an exceptionally light week of only 2 published warning letters, 1 of which was a compounding pharmacy which we cover below.

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COMPOUNDING PHARMACY:

  • Vital Rx, Inc. dba Atlantic Pharmacy and Compounding received a warning letter on Sept 26th 2018 based on the outcome of an inspection ending July 20th 2017 (not a typo). Violations include but are not limited to:
    • “Drug products were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health, causing your drug products to be adulterated.
    • Your firm has no assurance that glass vials used for filling injectable drug products are sterile.
    • Your firm used non-pharmaceutical grade filters to sterilize drug products. Specifically, the filter manufacturer precautions ‘Do not use this product for direct patient care applications; it was designed for laboratory use only.’
    • Your firm produced hazardous drugs without providing adequate cleaning of work surfaces and reusable equipment to prevent cross-contamination.”

UNTITLED LETTER:

  • Triad Isotopes, Inc. (Kansas City, MO) received an untitled letter on May 3rd 2018.

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About the Author

Barbara W. Unger

Barbara W. Unger 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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