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Showing items tagged as FDA-483

  • Three Common Reasons Biologics Companies Receive FDA Form 483 Notices

    21 December, 2017 by Marci Crane

    Biologics companies that wish to sell product in the United States should be ready at all times for a Food & Drug Administration (FDA) inspection. FDA inspectors have the authority to issue a Form 483 notice, which is a documented form that communicates when a company’s practices are not in compliance with regulatory standards.

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  • The “New Normal” for FDA Enforcement of the Food Industry: What You Need to Know and How to Prepare

    16 May, 2017 MasterControl

    With the parade of headlines announcing a new food-borne illness investigation, recall, or Food and Drug Administration (FDA) enforcement action continuing unabated, food company executives, quality assurance officers, and legal counsel are struggling to understand the new food enforcement paradigm.  Although every situation and company is different, in this article we identify four key developments that all food companies need to be aware of, as well as key steps that will help to prepare

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  • Identifying and Preventing Common Data Integrity Issues

    20 September, 2016 Joanna Gallant, Owner/President, JGTA LLC

    Because of the multitude of problems being found in regulatory agency inspections, data integrity is a hot issue for regulators around the world today. Data integrity is critically important to regulators for a variety of reasons, including patient safety, process and product quality. The integrity and trustworthiness of the data provides a baseline for the regulators opinion of the personnel and the company as a whole.

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  • 10 Things I Wish I’d Known Before Writing my FDA Response Letter

    25 August, 2016 Lisa Weeks

    If you’ve ever received a 483 or warning letter, as I have, you know the chaos that can ensue. The clock is ticking; the FDA requires a response to most compliance notices within 15 business days!

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  • Failure of Management with Executive Responsibility

    19 July, 2016 Dr. Christopher Joseph Devine, President, Devine Guidance International Inc

    For the second time in three weeks, Dr. D was able to quickly locate another rarely cited Form 483 observation: The failure of management with executive responsibility to actually review the quality management system they have been entrusted with managing. Now granted, from time-to-time it becomes a challenging task for the management representative to circle the wagons and corral all of the management-types into the executive conference room for a meeting focused on the performance of the quality management system (QMS). However, every Chief Jailable Officer (CJO) clearly understands the ramifications associated with not complying with the FDA’s sacred text, the quality system regulation (QSR). In fact, not being able to share at least documented evidence that a management review has occurred (agenda and sign-in sheet) is just not excusable. Heck, the agency even gives a ton of wiggle room with the “planned intervals” requirement, so holding at least one review annually should be a piece of cake. Right? Well, based on the performance of the device establishment targeted in this week’s guidance, the answer is a big “evidently not!” As many of the doctor’s friends and readers know, Dr. D is somewhat of a wisenheimer (look-it-up). However, when it comes entertaining the FDA during one of their friendly visits for a cup of coffee and an inspection, it is always Game On! Enjoy.

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  • How to Respond to FDA Inspection Observations, Including Those You Dispute

    26 January, 2016 Martin Browning, President, EduQuest, Inc.: FDA expert investigator and rule-maker for 22 years

    Although FDA is strapped with limited resources and competing priorities, the Agency continues to hammer regulated companies with FDA 483 inspection observations and Warning Letters.

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  • FSMA: Get Inspection-Ready with These Best Practices

    20 October, 2015 Melanie J. Neumann, J.D., M.S. Executive Vice President The Acheson Group

    Although FDA immediately gained increased authority for records access upon the signing of the Food Safety Modernization Act (FSMA) in January 2011, some companies haven’t gotten the memo yet.

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  • Infographic: FDA Inspections By The Numbers

    25 August, 2015 Tony Chen, CEO and Co-Founder of FDAzilla

    Up until recently, it has been difficult to get data on FDA inspections. Sure, the FDA publishes aggregate data every year, but what about the granular data on every inspection?

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  • 7 Steps to Respond to an FDA 483 Inspection Observation

    15 July, 2014 by Robert Packard, President, Medical Device Academy

    Responding in 15 days is one of seven steps on how to respond to an FDA 483 inspection observation. This blog post also includes advice from a former FDA investigator.

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  • Understanding the Relationship between GMPs and Adulteration

    25 September, 2014 Marc C. Sanchez, Contract In-House Counsel & Consultants, LLC

    Good Manufacturing Practices (GMPS or cGMPS) are a bit of a misnomer. The name implies the practices only apply to manufacturers, but the limitation is in name only. It suggests a rigid system of procedures more suitable for multinational corporations than start-ups, mid-size companies, or importers. In truth GMPs are policy goals that do not specify how an activity is done, just the result it should achieve. The name also lacks any link back to the overarching purpose of the practices. GMPs are not a scoring or rating system. Instead GMPs are a crucial link to avoiding adulteration and ensuring quality. The practices set a floor or safety net of minimum facility sanitation practices to ensure cosmetics are not indirectly contaminated. It also establishes a consistency that secures quality. GMPs are oft cited by the FDA following facility inspections in Form 483s and Warning Letters because it provides a window into the culture and compliance mindset of a facility. That mindset suggests the likelihood of adulteration or larger compliance violations.

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  • FDA vs. EU Inspections: Similarities & Differences

    14 October, 2014 Marie E. Dorat, CQA, CAA IPRF, LLC – RA/QA Consulting & International Product Registration EU-FDA Joint Initiative

    The U S Food and Drug Administration (FDA) and European Medicines Agency (EMA) Good Clinical Practice (GCP) initiative started a joint inspection program in September 2009.  This inspection program targets investigator sites, sponsors, and contract research organizations (CROs) in either the US or the European Union (EU).

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  • Conducting an Effective Failure Investigation: Going Deep Enough to Hit Root Cause

    24 April, 2014 by Christine Park, Quality Architech, Christine Park & Associates

    The FDA has increased focus on the effectiveness of failure investigations during recent inspections. A review of recent 483 observations and warning letters clearly demonstrate the agency’s current concern about the adequacy of failure investigations to really identify root cause.

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  • Responding to FDA 483s: Do’s, Don’ts, and When to Call In a Remediation Partner

    14 February, 2014 Lisa Weeks, Marketing Communications, MasterControl Inc.

    Operating under the oversight of the FDA and other global regulatory agencies creates a climate of transparency for regulated companies; any misstep can result in severe consequences such as product seizures, recalls, or company closure. Therefore, the way you respond to FDA Form-483 observations, warning letters, and other critical events is vital to your company's survival. Having a sound quality management system in place is critical, but when remedial action is necessary, time is of the essence. After all, you have only 15 working days from the receipt of the 483 to respond!

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