Canadian Manufacturer Receives FDA Warning Letter

FDA sent a warning letter, dated Aug. 2, 2017, to Cellex-C International Inc. after inspectors found violations of current good manufacturing practices (CGMPs) at the company’s Toronto facility. The facility was inspected by the agency from Jan. 16–19, 2017. The violations included failure to test product and establish adequate procedures.

Specifically, FDA inspectors found that the company had failed to test incoming API and other components to determine identity, purity, strength, and other specifications. The company stated it relied on its supplier’s certificate of analysis for such testing. FDA stated in the letter that the company “must conduct at least one specific identity test to analyze all incoming components. You may not rely on your supplier’s COA to verify the identity of your components. Your response was also inadequate because you did not indicate how you would address your failure to test all incoming components for specifications other than identity.”

Additionally, written procedures for the company’s quality unit were lacking. FDA stated in the letter that the company must provide the agency these written procedures. The company’s manufacturing processes were not validated, according to the letter, and it must commit to validating its processes. FDA is requested that the company provide the agency with an action plan for validation.

The agency also cited the company for incomplete batch production records. “They lacked information regarding critical steps in your filling and packaging operations … According to your response, you have revised your manufacturing formulation worksheet. Your response is inadequate. The worksheets you provided still omitted information about your manufacturing processes, such as identification of all critical equipment used during manufacturing, descriptions of the final drug product containers and closures, and details about in-process and finished product sampling,” the agency stated in the letter.

FDA suggested the company hire a consultant that specializes in CGMP requirements. The agency also placed the company on Import Alert 66-40 on June 2, 2017.

Source: FDA