FDA 483 - Foothills Professional Pharmacy, LTD - October 01, 2021

On October 1, 2021, the FDA issued a Form 483 to Foothills Professional Pharmacy, LTD, a producer of non-sterile drugs located at 4545 E Chandler Blvd, Ste 100, Phoenix, AZ 85048. The inspection, conducted from September 27 to October 1, 2021, by Investigator Nicholas L. Hunt, identified issues related to inadequate cleaning and cross-contamination prevention.

The primary observation (Observation 1) noted that hazardous and non-hazardous drugs were produced without adequate cleaning of work surfaces and utensils. Specifically: A) Residue and loose powder were found on two stainless steel bowls designated as clean in the hazardous production laboratory on September 27, 2021. These bowls were used for mixing bulk lots, including cholesterol/lovastatin cream. This was a repeat observation. B) A cleaning solution labeled as 200 ppm did not contain the stated concentration. The master and batch production records indicated a requirement for 200 ppm solution, but the active ingredient label showed a different percentage, resulting in an actual concentration of approximately 4870 ppm. This solution, used for deactivation, decontamination, and sporicidal disinfection, had been in use since June 2021. This was also a repeat observation. C) Clear packing tape covered a port on a production hood, with