Cooking Pots and Household Power Tools: FDA Warns California Drugmaker
The US Food and Drug Administration’s (FDA) 12 July warning letter for BioDiagnostic International featured an odd note about halfway down the CGMP violations: “You use kitchen cooking pots and household power tools to manufacture your drug product used for biopsy procedures.”The surprising detail – part of one of four CGMP violations cited – comes as an FDA investigator further found an employee food prep station within its Brea, CA-based drug manufacturing area “with no separation between open manufacturing equipment, cooking utensils, and personal-use items.”
Parts of the facility to manufacture product (the name of the drug is redacted from the letter) were also “open to the outdoors,” which FDA said increases “the likelihood of your drug products becoming contaminated.”
The firm, which does note have a quality control unit, also routinely released drug product “without testing for chemical or microbial quality.”
A call made to BioDiagnostic by Focus went unreturned.
BioDiagnostic International 7/12/18