The FDA told a compounding pharmacy that it is failing to meet the requirements for two outsourcing facilities in San Jose, Calif., according to a warning letter posted March 29 on the agency’s website.
The Food and Drug Administration said that based on an inspection that ended Oct. 7, 2014, Leiter’s Compounding’s facility located at 17 Great Oaks Blvd. is failing to meet the conditions under Section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA) for drugs produced by an outsourcing facility to be exempt from the agency’s drug approval requirements.
The Drug Quality and Security Act of ...
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