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In the highly regulated U.S. market, product recalls and enforcement actions can significantly impact a company’s reputation, finances, and consumer trust. Whether involving food, dietary supplements, cosmetics, or medical devices, recalls are often initiated due to safety concerns, mislabeling, contamination, or non-compliance with FDA regulations. Having a proactive recall and [...]
FDA compliance does not end after a product receives clearance or approval. Companies must actively manage post-market surveillance to ensure ongoing safety, effectiveness, and regulatory compliance. Failure to meet post-market obligations can lead to recalls, penalties, import alerts, and reputational damage. At XPRO AMERICA, we provide comprehensive post-market surveillance and [...]
In the highly regulated pharmaceutical and healthcare industry, compliance with the U.S. Food and Drug Administration (FDA) is not optional it is a business necessity. When drug products are found to be misbranded, adulterated, or unsafe, the FDA may require a recall or initiate enforcement actions. Mishandling a recall can [...]