As going gets tough, pharma firms revisit past decisions

FDA issues guidance on conducting remote interactive evaluations during the COVID-19 pandemic

For example, the agency will not issue a Form FDA 482 or a Form FDA 483 during the course of remote interactive evaluation. Background. With…

Breaking Down FDA’s New Remote Monitoring Strategy

The observations, however, will not be issued on a Form FDA 483 and will not be considered inspectional observations. The agency does request, …

FDA blasts Colombian drug manufacturer in warning letter for not properly addressing API flaws

But that’s exactly how a Colombian API maker responded following a Form 483, and now the agency is reading the riot act. The FDA issued…

An Introduction To Trending In Environmental Monitoring Programs

An FDA 483 observation dated May 2, 2014 stated that “[REDACTED] Water trending records are not always accurate or supported by raw data.

Form 424B5 Aptorum Group Ltd

… or sufficiently respond to an FDA Form 483 or subsequent Warning Letter, this could impair our ability to market our products in a cost-effective…

Bristol Myers scales up cell therapy production with liso-cel nod in hand and another approval …

The therapy had a circuitous road to its FDA nod, including a series of manufacturing snafus at a Lonza Houston contract site that led to…

Iris Recognition in Access Control Market Trends, Analysis, Demand and Global Industry Research …

Download FREE sample copy of Iris Recognition in Access Control market report @ https://www.reportsanddata.com/sample-enquiry-form/483 …

EAS Due Diligence Assessments Support Private Equity and Venture Capital Firms with …

… DMFs, NDIs, 510(k)s and more; to FSMA compliance, expert witness services, due diligence assessments, or support after receipt of a FDA form 483 …

Form 8-K Biohaven Pharmaceutical For: Mar 17

… manufactured or distributed by the Company (“Applicable Laws”); (ii) has not received any FDA Form 483, notice of adverse finding, warning letter, …

Trends In FDA Quality System Inspections: 3 Takeaways To Ensure Future Success

The Form 483 documents the regulatory clause(s) that is violated for the audited project and is informally provided to the team involved in the inspection …