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

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.