FDAnews Drug Daily Bulletin

Compounder Warned for Long List of GMP Violations

July 5, 2017

A Texas-based compounder specializing in hormone therapies was warned by the FDA for extensive cGMP violations as well as producing drugs for which there was no valid prescription.

Arta Shaun Noorian, founder and owner of Empower Clinic Services which also does business as Empower Pharmacy, was issued a Form 483 in November 2015 and the FDA was not satisfied with the steps the compounder has taken to remedy problems since then.

Continued cGMP problems, according to the May 25 warning letter, include Empower’s failure to establish and follow written procedures for microbiological contamination; failure to establish and follow a written testing program to assess the characteristics and stability of compounded drugs and failure to establish an adequate system for establishing, maintaining and monitoring aseptic lab conditions or drug processing areas.

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