FDA 483 - Foothills Professional Pharmacy, LTD - October 24, 2018

This FDA Form 483 was issued to Pujan A. Patel, Owner of Foothills Professional Pharmacy, Ltd., located at 4545 E. Chandler Blvd, Ste. 100, Phoenix, AZ 85048. The establishment is a producer of non-sterile drugs. The inspection, conducted by Investigators Nicholas L. Hunt and Christopher M. Jenner, concluded on October 24, 2018.

The inspection revealed several insanitary conditions or direct violations of section 503A of the Act. Key observations include:

1. **Failed Potency Testing:** The firm released sub-potent finished drug products, specifically Liothyronine 62.5 mcg/capsule (44.5% assay) and Testosterone 3 mg mini troche (79.3% assay). Additionally, four bulk intermediates failed potency testing (sub-potent and super-potent), and some were used to produce and release finished products after receiving failing results. 2. **Cross-Contamination Risk:** Beta-lactam and non-beta-lactam drug products were produced using shared equipment and utensils, with inadequate containment and segregation to prevent cross-contamination. 3. **Inadequate Disinfectant Agents:** The firm used a solution labeled "Not for sanitization or disinfection" as the primary cleaning and decontamination agent for direct product contact surfaces, equipment, utensils, and hoods.