FDA 483 - DNA Pharmacy Services Inc dba Palm Beach Compounding - August 13, 2014

This FDA Form 483 was issued to DNA Pharmacy Services Inc dba Palm Beach Compounding, a producer of non-sterile drugs located in Jupiter, FL, following an inspection from August 11-13, 2014. The inspection identified three observations.

Observation 1 notes the absence of a written testing program for assessing drug product stability. Specifically, there is no data to justify a 9-month beyond-use date (BUD) for Testosterone Cypionate Injection 220mg/mL Lot 03/02/2014:1106, produced on March 2, 2014, and distributed with a BUD of December 27, 2014. The firm's generated stability data only supports a 3-month BUD for this product.

Observation 2 states that each batch of drug product purporting to be sterile and pyrogen-free is not laboratory tested for conformance. Specifically, Testosterone Cypionate Injection 220mg/mL Lot 03/02/2014:1106, distributed with a 9-month BUD, lacks current sterility and endotoxin testing data to demonstrate its safety, effectiveness, and stability for that duration.

Observation 3 concerns equipment and utensil maintenance. White residue and scratches were observed inside a component of a high-torque blender used for blending inactive pharmaceutical ingredients before encapsulation. Additionally, materials