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Pharmaceuticals / Inspections and Audits

California Outsourcer Warned for Unapproved, Adulterated Drugs

Nov. 5, 2018
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The FDA hit Auro Pharmacies of La Habra, California, with a warning letter for unapproved and adulterated drugs and significant good manufacturing practice violations at its outsourcing facility.

The facility had no FDA-approved applications on file for its compounded drugs and it was cited for compounding misbranded and unapproved new drugs.

Agency inspectors also observed serious CGMP violations during a June 13-29, 2017, inspection and noted that the facility failed to qualify for exemptions from FDA oversight under section 503B of the Food, Drug and Cosmetic Act.

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