What The FDA’s Inspections Q&A Guidance Really Means: It’s Time To Offer Virtual Inspections
Compliance experts see possibilities in offering video tours as the FDA offers “holistic” approach to assessing sites during pandemic.
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Lupin CEO Vinita Gupta shares plans to shift manufacture of albuterol and some other products to its US facilities, with a rollout of a generic to Teva’s ProAir expected soon. Enthused by Lupin’s first biosimilar introduction In Europe with etanercept and looking to up the company’s digital game, the executive says Amazon’s entry into India’s e-pharmacy space is not a near-term worry
Legal experts say any firm distributing products associated with COVID-19 should expect to receive the highest level of scrutiny as the US FDA resumes inspections and uses its enforcement muscle to prohibit companies from making adulterated products, such as hand sanitizers, or making fraudulent claims.
Invalidated OOS results are ‘red flags’ during FDA inspections and ‘denying, delaying, limiting or refusing’ a drug inspection proposed by the agency could have serious consequence, participants at a recent webinar on best practices for responding to Form 483s and warnings letters heard.