Compounding Pharmacy of America – FDA 483, Feb 1, 2018

This FDA Form 483 was issued to The Compounding Pharmacy of America, located at 6216 Highland Place Way, Suite 101-A, Knoxville, TN 37919. The inspection, conducted by Brandon C. Heitmeier, took place from January 23-26, 2018; January 29, 2018; and February 1, 2018. The firm is identified as a producer of sterile and non-sterile drugs. The report was issued to Victor A. Poteet, Co-owner & CEO.

Two observations were noted:

1. Media fills did not adequately simulate aseptic production operations, failing to incorporate worst-case activities and conditions. Specifically, the firm's large batch media fill used (b)(4) vials, while routine sterile drug product batches, such as (b)(4) (lidocaine) and Methylcobalamin 1000 MCG/ML, frequently exceed (b)(4) vials, with examples provided of batch volumes of (b)(4) and (b)(4) respectively.

2. Hazardous drugs were produced without adequate containment, segregation, and/or cleaning to prevent cross-contamination. Specifically, hormone and non-hormone drug products are prepared and processed in the same sterile prep area and clean room, utilizing the same equipment ((b)(4) & LAFH