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.