OTC Topicals Firm's Regulatory Problems More Than Skin Deep
FDA's warning letter submitted following an October 2016 at Phillips Co.'s Millerton, Okla., facility states that the company does not appear committed to correcting the GMP, labeling and branding problems Office of Regulatory Affairs officials found.
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Poor data integrity at Asian API firms, poor quality programs at foreign OTC firms and poor sterility assurance at US compounding pharmacies were the main factors leading US FDA to issue 110 drug GMP warning letters in 2016, a huge increase from prior years. Article is first of four-part series in our annual analysis.
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