FDA 483 - Empower Pharmacy - January 24, 2018

On January 24, 2018, the FDA issued a Form 483 to Empower Pharmacy, an outsourcing facility located at 5980 West Sam Houston Parkway North Suite 300, Houston, TX 77041. The inspection, conducted from January 10-24, 2018, identified one repeat observation concerning a failure to thoroughly investigate unexplained discrepancies or batch failures.

Specifically, the FDA noted that Empower Pharmacy's investigation into an endotoxin failure for Lot No. 36029 (Tri-Amino CL-Arginine HCL/L-Citrulline/L-Ornithine) on October 25, 2017, was incomplete. The firm failed to document a root cause, implement corrective or preventative actions, or evaluate the impact on other associated lots.

Similarly, an investigation into a potency failure for Lot No. 35979 (HCG Lyophilized 3000 IU/vial) on October 16, 2017, was also found incomplete. Empower Pharmacy did not document a root cause, implement corrective or preventative measures, or assess the impact on other associated lots for this failure. The observation was issued to Mr. Arta Shaun Noorian, Founder and CEO.