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Quality Issues Found at Canadian Facility
FDA sent a warning letter to Deserving Health International Corp. after inspectors found CGMP violations including failure to prevent microbiological contamination.
FDA sent a warning letter, dated Dec. 18, 2017, to Deserving Health International Corp. following an inspection of the company’s Richmond, British Columbia facility conducted from July 10–14, 2017. The warning letter describes current good manufacturing practice violations found at the facility, which included failure to properly prevent microbiological contamination of product.
Specifically, FDA inspectors found that the company had failed to follow written procedures to prevent microbiological contamination of sterile drug product or validate aseptic and sterilization processes. The letter states that product was manufactured in unsuitable and non-sterile water. While the company stated they were in the process of qualifying sterile processing equipment, FDA stated in the letter that the company must perform a risk assessment for all batches of sterile drug product distributed in the United States.
Quality procedures were also found lacking. According to the agency, the company failed to establish an adequate quality control unit and procedures. There was also a lack of proper documentation of quality procedures including annual product reviews, batch record reviews, and approval/rejection documentation.
Adequate testing of drug components was also deficient. “You did not test each raw material lot for identity before permitting use of the component in manufacture of your drug products. For instance, you failed to perform identity tests on components including but not limited to glycerin, salicylic acid, and penicillium notatum used in your finished drug products. Furthermore, you failed to determine whether each component lot conformed with all appropriate written specifications for purity, strength, and quality before using them,” the agency stated in the letter.
Because of the violations found and the company’s lack of proper response, FDA placed the company on Import Alert 66-40 on November 2, 2017. The agency recommended the company hire a consultant to address the violations.
Source: FDA
