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 […]
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 […]
According to Zachary Brennan of Endpoints News (see here), the FDA announced yesterday that it will hit the pause button again on upcoming routine domestic inspections due to the COVID-19 Omicron variant’s rapid spread. The initial pause will be for two weeks, but, depending on the state of knowledge about the status of the Omicron […]
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 […]
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 […]
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 […]
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 […]
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 […]
In March 2020, the FDA postponed all inspections of domestic and foreign drug manufacturing facilities due to the COVID-19 pandemic. However, drug products manufactured overseas are still entering the U.S. market, prompting some U.S. Senators to voice their concern. On November 10th, two members of the Senate Health, Education, Labor, and Pensions (HELP) Committee sent […]
On November 11, 2020, Lachman’s Scott Deckebach MBA, Director, Compliance, Lachman Consultants will be participating in a panel discussion during the 2020 Bio/Pharma Virtual Congress, “‘New Normal’ for Quality Practices”. This discussion will review quality and regulatory challenges amid the pandemic, focusing on new technologies such as remote monitoring, risk-based quality management, Annex 1 changes […]
