How to Prepare for an FDA Inspection – Important Things to Know, from the Perspective of a Former Investigator (Part 3)

In our previous installment on inspectional preparation and conduct, we covered recommended actions to be inspection ready, how to interact with FDA, and how personnel should conduct themselves during an FDA inspection. In today’s installment, we will cover what happens after the inspection, focusing on responding to an FDA 483 and inspectional outcome decision making. […]

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How to Prepare for an FDA Inspection – Important Things to Know from the Perspective of a Former Investigator (Part 2)

In our previous installment, Tamil Arasu, former investigator with FDA, detailed preparations that a firm can make in advance of an FDA inspection, as well as details on the types of inspections that FDA performs on drug firms. In today’s post, Tamil will describe appropriate conduct during an inspection, including both the personnel that will […]

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How to Prepare for an FDA Inspection – Important Things to Know from the Perspective of a Former Investigator (Part 1)

When an FDA investigator walks into your facility and informs you that they are going to conduct an inspection, a tense moment may arise even at the most cGMP (Current Good Manufacturing Practices) compliant facility. Paging the employees to inform them of the presence of FDA at the facility is a common occurrence so that […]

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Domestic Inspections to Resume Today

In its “FDA Roundup: February 4, 2022,” the FDA announced that “on Feb. 2, the FDA determined that beginning on Feb. 7, the agency will resume conducting domestic surveillance inspections across all commodities given the decline in COVID-19 cases across the country.” The FDA says that it will continue to conduct mission‑critical foreign and domestic […]

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OGD Published GDUFA III Commitment Letter

Every 5 years, the user fee programs (UFAs) are renegotiated and, for each UFA program, there is a commitment letter that outlines the agreed-upon goal dates and program enhancements that will dictate the five-year reauthorization period when Congress passes the Reauthorization Act (likely in mid to late FY 2022). This is a piece of must-pass […]

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Digital or electronic thermometer with high temperature 98,6 Fahrenheit in doctors hand. Doctor or nurse in protective PPE suit, face mask, safety googles and rubber gloves demonstrates temperature caused by covid 19, coronavirus or Sars-Cov-2

Domestic Inspections Back to Normal – Mission Critical Still for Foreign In-person Reviews

With the news that domestic inspections are back on track the question comes with what is the backlog and how long will it take to slug through the outstanding inspections work?  Question number 2 is then what do we anticipate seeing from these new domestic inspections? With it being over a year+ (March 2020) since […]

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Remote Inspection Guidance Now A Reality But Will It Solve the Backlog of Inspections?

Yesterday, the FDA issued a long-awaited guidance titled Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency (here).  The guidance notes that the Agency will determine whether remote inspections will occur and which tools are appropriate as alternatives to on-site inspections but indicates that it will not accept […]

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Lachman Consultants’ Webinar Presents Latest Virtual Solutions for Remote Audits and FDA Inspection Preparation

There’s still time to register for Lachman Consultants’ free webinar, “Looking Ahead: Virtual Auditing for FDA Inspection Preparedness: Right Now, Next Year and Beyond.”  The event, which takes place Tuesday, December 15, 2020, from 11:00 am to 11:45 am EST, is an in-depth look at how organizations regulated by the FDA can utilize new virtual […]

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A Virtual Solution: Lachman Consultants’ Webinar Details Top Strategies & Tools for Remote Auditing and FDA Inspection Preparation

The Coronavirus pandemic has forced organizations worldwide to adjust current business goals and objectives drastically. One priority that hasn’t changed for companies regulated by the FDA is inspection preparedness and compliance. Although this process typically requires working on-site with qualified third-party experts, auditing for FDA inspection preparedness can now occur over a remote connection as […]

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