# FDA WARNING_LETTER - INS Bioscience Berhad, HLS International Sdn. Bhd., Easy Pha-max - July 15, 2013

Source: https://www.keypedia.com/records/warning_letter/ins-bioscience-berhad-hls-international-sdn-bhd-easy-pha-max/814ee5f2-787d-46bf-b610-b3f6aecfd7b0

> FDA WARNING_LETTER for INS Bioscience Berhad, HLS International Sdn. Bhd., Easy Pha-max on July 15, 2013. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: INS Bioscience Berhad, HLS International Sdn. Bhd., Easy Pha-max
- Inspection Date: 2013-07-15
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA issued a Warning Letter to INS Bioscience Berhad, HLS International Sdn. Bhd., and Easy Pha-max, identifying their products as unapproved new drugs and misbranded drugs. The review of their websites (www.insbioscience.com, www.hlssuccess.com, and www.easyphamax4u.com) revealed multiple violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Specifically, the product "Insupro Forte" was found to contain undeclared glyburide, an active pharmaceutical ingredient (API) in FDA-approved drugs for type 2 diabetes. This makes "Insupro Forte" an unapproved new drug under sections 201(p), 301(d), and 505(a) of the FD&C Act, as it is not generally recognized as safe and effective and lacks an FDA-approved application. Furthermore, it is misbranded under sections 502(f)(1), 502(a), and 502(f)(2) because it lacks adequate directions for use, its labeling is false and misleading due to the undeclared API and claims of "no side effects," and it lacks adequate warnings for potential serious health risks like severe hypoglycemia.

Other products, "Bio-Prolife," "Bio-Refine," and "Pro Can," are also considered unapproved new drugs and

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Company: https://www.keypedia.com/companies/ins-bioscience-berhad-hls-international-sdn-bhd-easy-pha-max/6475c0b3-d22b-4670-a043-fcad5cf360e1

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c