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Pharmaceuticals / Inspections and Audits

Singapore Firm Draws Warning for Unapproved Drug, Quality Violations

April 29, 2019

Luen Fook Medicine’s Singapore facility drew a warning letter from the FDA for making unapproved drug claims and for repeat quality violations.

The FDA inspected the facility from Dec. 10-14, 2018 and deemed the company’s African “Sea Coconut” sore throat syrup to be an unapproved new drug because of its formulation and labeling. The product was marketed as a demulcent for relief of minor pain and inflammation.

The agency also flagged a problem with the active ingredient. Over-the-counter drug products for use as a demulcent are subject to the tentative final monograph for Oral Health Care Drug Products for Over-the-Counter Human Use. The monograph permits elm bark only in a solid dosage form at a concentration of 10-15 percent — but the sore throat syrup listed 65 milligrams of elm bark in each five-milliliter teaspoon in a liquid dosage form.

The FDA also blasted the firm’s quality unit for failing to properly oversee active ingredient testing, cleaning validation and process validation.

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