FDA Sent These Warning Letters To Pharma/Device Companies

BARBARA W. UNGER | August 20, 2019

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We cover three drug warning letters, one issued to a compounding pharmacy, one device warning letter and one in the food area that is a ‘first of its kind’.  One of the drug warning letters is issued to a firm that recovered solvents that were used in the manufacture of the API of valsartan products that contained the multiple potential carcinogens.  Note that Swiss Medic inspected the firm 6 days before FDA did and issued a report of non-compliance.

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OIA partners with healthcare providers such as health systems, academic medical centers, and radiology groups to develop, market and operate quality, patient friendly, service oriented outpatient imaging centers. OIA’s business model is to invest equity in each project alongside its local partners while providing development, management, marketing, billing and collection services to the joint venture.

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Spotlight

Outpatient Imaging Affiliates

OIA partners with healthcare providers such as health systems, academic medical centers, and radiology groups to develop, market and operate quality, patient friendly, service oriented outpatient imaging centers. OIA’s business model is to invest equity in each project alongside its local partners while providing development, management, marketing, billing and collection services to the joint venture.

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