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Regulatory Focus™ > News Articles > 2019 > 5 > Repeat GMP Violations Spur FDA to Ban Canadian OTC Drugmaker Imports

Repeat GMP Violations Spur FDA to Ban Canadian OTC Drugmaker Imports

Posted 14 May 2019 | By Ana Mulero 

Repeat GMP Violations Spur FDA to Ban Canadian OTC Drugmaker Imports

A US Food and Drug Administration (FDA) inspection at a Canada-based over-the-counter (OTC) drug manufacturing facility revealed violations of good manufacturing practices (GMP)—similar to those cited in 2012 and 2014.

A new FDA warning letter cites Petra Hygienic Systems International for four violations of GMP regulations for finished pharmaceuticals, following the site inspection FDA conducted last December. Imports from the firm have been blocked from entering the US since 25 March.

The firm failed to conduct finished product quality testing per National Formulary (NF) monograph requirements prior to releasing and distributing a lot of OTC drug products to the US market, according to the warning letter. FDA compliance officer Kevin Maguire added that the firm’s assay release specifications differ from the NF monograph, which allows for “super potent drug products.”

FDA also flagged failures to test incoming components that the firm had been using to manufacture OTC drug products to determine identity, purity, strength and quality. The firm was found to have been using results from its suppliers’ certificates of analysis, instead, without establishing supplier reliability.

A lack of validation for the methods used for cleaning equipment and written procedures for functions such as quality unity responsibilities, as well as corrective and preventive actions, were cited by FDA too.

Similar violations were cited during FDA site inspections in March 2012 and December 2014, though the firm had proposed remediation actions. “Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate,” said Maguire.

The warning letter escalates FDA Form 483 observations after the firm’s response was deemed inadequate. FDA also directs the firm to include an action plan for testing reserve samples and each component lot for conformity with the appropriate written specifications, a cleaning validation summary report and other information in its response.

Warning letter

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