# FDA 483 - Empower Pharmacy - January 24, 2018

Source: https://www.keypedia.com/records/483/empower-pharmacy/936c297e-2ca5-453c-9af7-61cae0d6768c

> FDA 483 for Empower Pharmacy on January 24, 2018. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Empower Pharmacy
- Inspection Date: 2018-01-24
- Product Type: Drugs
- Office Name: Dallas District Office
- Summary: 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.

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## Related Officers

- [Sha'tina R. Alridge](https://www.keypedia.com/people/shatina-r-alridge/07a5b90c-87c1-43c2-b92b-852de459d964)
- [Jason R. Caballero](https://www.keypedia.com/people/jason-r-caballero/c2c8d281-0d02-459f-9541-bc04cb6d0a59)
- [Investigator](https://www.keypedia.com/people/shatina-r-alridge/f4715fcf-fb27-4ef3-8289-adfff2db62bf)

Company: https://www.keypedia.com/companies/empower-pharmacy/d0830ab6-58b6-4661-95a6-31c44f7c46fe

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9