FDA Found Violations of cGMP in Canadian OTC Manufacturer Facility


FDA sent a warning letter, dated May 7, 2019, to Petra Hygienic Systems International, LLC after an inspection of the company’s Concord, Ontario facility found violations of current good manufacturing practices (CGMPs). The violations included a failure to test product for API identity and strength, failure to validate outsourced materials, and a lack of written cleaning procedures.

During the inspection, which was performed Dec. 17–21, 2018, inspectors found that the company had released over-the-counter (OTC) drug products without conducting quality testing on finished products as required by National Formulary (NF) monographs or using the required assay release specifications. The agency asked the company to provide an action plan for testing reserve samples of finished OTC products that were distributed in the United States. “If such testing reveals that you released drug products that did not meet specifications for identity or strength of active ingredients, indicate what corrective actions you have taken or will take, such as notifying customers or recalling products,” the agency stated in the letter.

According to the letter, the company relied on component suppliers’ certificates of analysis (CoAs) instead of testing components for their identity, purity, strength, and quality. This practice is against requirements in 21 Code of Federal Regulations 211.84(d)(2), FDA stated. The agency is asking the company to describe how it plans on testing each component lot for conformity and how it will test suppliers’ results at regular intervals.

Cleaning and maintenance of equipment was also lacking at the facility. “You have not validated the methods you use to clean your equipment. Inadequate removal of residues from manufacturing equipment during cleaning can lead to cross-contamination of products subsequently manufactured on the non-dedicated equipment,” the agency stated. The company must provide a cleaning validation summary report and an evaluation of all drug product lots for possible cross-contamination.

FDA stated in the letter that similar CGMP violations were found in previous inspections conducted in 2012 and 2014. The agency placed the firm on Import Alert 66-40 on March 25, 2019 and stated, “Until you correct all violations completely and we confirm your compliance with CGMP, FDA may withhold approval of any new applications or supplements listing your firm as a drug manufacturer.”