HBW Regulatory News: Canadian OTC Firm Warned On GMPs, Homeopathic Guidance Comment Extended

Canadian contract manufacturer Apollo Health And Beauty Care Inc. promotes itself as a personal care product provider but the US Food and Drug Administration considers its products OTC drugs and says the firm isn't meeting good manufacturing practices requirements. In a warning letter published 7 January following an inspection in August, the FDA Center for Drug Evaluation and Research's offices of manufacturing quality and compliance instructed the North York, ON, firm to provide information including results from a comprehensive investigation into the extent of the inaccuracies in its data records and reporting, including results of review for drugs distributed to the US and a detailed description of the scope and root causes of its data integrity lapses; and a current risk assessment of the potential effects of the observed failures on the quality of its drugs, including "analyses of the risks to patients caused by the release of drugs affected by a lapse of data integrity and analyses of the risks posed by ongoing operations."

The warning submitted on 23 December, after the firm's response submitted in September failed to state details on corrective...