FDA 483 - Advanced Nutraceuticals, LLC - October 29, 2020

This FDA Form 483 was issued to Advanced Nutriceuticals, LLC, a producer of sterile drug products located at 836 E 86th St, Indianapolis, IN 46240-1806. The inspection, conducted from October 13 to October 29, 2020, identified significant deficiencies in aseptic processing and quality control.

Observation 1 details that aseptic processing was performed outside a certified ISO 5 area. Specifically, on October 20, 2020, dispensary staff, without proper gowning (exposed hands, hair, streetwear), filled 1ML syringes with Testosterone Cypionate w/ Olive Oil stock solution (LOT EXP 11/30/2020) in an unclassified Dispensary Area. These filled syringes were assigned a 40-day Beyond Use Date (BUD) of November 30, 2020. The document notes that any employee in this area could perform this task without documentation or training. From August 3 to September 25, 2020, dispensary staff filled and dispensed multiple batches of Testosterone Cypionate w/ Olive Oil and Nandrolone w/ Olive Oil syringes in the Dispensary Area, assigning the stock solution's expiry dates to the filled syringes. Each batch contained varying numbers of syringes.

The document indicates further observations beyond the first, implying additional violations related to quality systems