FDA WARNING_LETTER - Petra Hygienic Systems Int Ltd - December 21, 2018

The FDA inspected Petra Hygienic Systems International LLC's drug manufacturing facility in Concord, Ontario, from December 17 to 21, 2018, identifying significant violations of current good manufacturing practice (CGMP) regulations (21 CFR parts 210 and 211), rendering their drug products adulterated. The firm's January 11, 2019, response was deemed inadequate. Key violations include releasing OTC drug products to the U.S. market without required finished product quality testing per NF monograph requirements, using assay release specifications that allow for super potent drug products, and failing to test incoming components for identity, purity, strength, and quality, instead relying on unvalidated supplier certificates of analysis. Additionally, the firm lacked validated equipment cleaning methods, adequate written procedures for various functions, and failed to follow existing procedures. The FDA noted inadequate quality systems and cited repeat observations from previous inspections in 2012 and 2014, indicating insufficient executive management oversight. As a result, the FDA placed the firm on Import Alert 66-40 on March 25, 2019. The company must provide comprehensive action plans and timelines for testing reserve samples, validating component testing, validating cleaning methods, and establishing a robust quality system. Failure to correct these violations may lead to continued refusal of admission of articles into the U.S. and withholding of new application approvals.