Canadian Drugmaker Warned for Sterility, Verification, Procedural Issues
The FDA issued a warning letter to Deserving Health International after an inspection of the drug manufacturer’s facility in Richmond, British Columbia in July revealed sterility problems, failure to verify the identity of drug components and other significant violations.
The agency was not satisfied with the firm’s responses to the initial inspection report and it placed the company on an import alert on Nov. 2.
The agency’s investigator found the facility did not follow written procedures to prevent contamination of drug products said to be sterile. Specifically, the firm’s manufacturing process for a homeopathic drug product, Symbio Muc Eye Drops 5X, could not assure the product’s sterility, as it was produced using non-sterile water. The company agreed to recall the product in September.