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    FDA’s document-based inspections prompt warning letters for GMP violations

    The US Food and Drug Administration (FDA) on 13 April warned South American active pharmaceutical ingredient (API) manufacturer Proquimes SA Productos Quimicos Especializados SA for a multitude of good manufacturing practice (GMP) violations. The letter joins three others the agency has issued since the beginning of the year that are based solely on a records review and not onsite inspections.   The warning letters signal the agency’s increasing reliance on a review of...
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    Special Counsel raises questions about FDA’s biologics inspections

    In closing a whistleblower case concerning allegations of downgraded inspection findings raised by a former investigator on the US Food and Drug Administration’s (FDA) Team Biologics, US Special Counsel Henry Kerner wrote to President Joe Biden that he is “troubled” by many aspects of the case.   In the letter, Kerner says that FDA’s report on its investigation of the allegations “meets all the statutory requirements but that the findings do not appear reasonable” and ...
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    FDA’s inspection backlog: GAO raises concerns as delays mount

    For decades, the Government Accountability Office (GAO) has raised concerns about the US Food and Drug Administration’s (FDA) inspections program. Now, a year after the agency halted most of its foreign and domestic inspections due to the COVID-19 pandemic, GAO warns that the ensuing backlog could take years to clear.   In a new report and testimony before the House Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related...
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    FDA outlines process for communicating record requests findings

    The US Food and Drug Administration (FDA) says it has put in place an interim process to communicate issues identified during record reviews done in lieu of or in advance of preapproval inspections with drugmakers and consider their responses before taking action on an application.   The agency says the interim process will continue throughout the COVID-19 public health emergency and may be extended to other drug inspection programs, including routine surveillance insp...
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    Inspections: GAO calls on FDA to plan for backlog, review alternatives

    In a nearly 350-page report to Congress on the federal government’s COVID-19 response, the Government Accountability Office (GAO) calls on the US Food and Drug Administration (FDA) to review its inspections approach and come up with a plan to address its looming backlog.   Pandemic inspection alternatives   In the early days of the pandemic, FDA halted non-mission-critical foreign and domestic inspections and relied on alternative tools, such as inspection reports ...
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    FDA details review timelines as facility assessment-related CRLs pile up

    In guidance released Monday, the US Food and Drug Administration (FDA) provides the timelines it will stick to when reviewing responses to complete response letters (CRLs) for drugs and biologics when a facility assessment or inspection is required in order for the agency to make a decision on the application.   FDA’s ability to conduct on-site inspections has been dramatically curtailed amid the COVID-19 pandemic due to public health concerns and travel restrictions. ...
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    FDA issues pandemic inspections FAQ guidance

    The US Food and Drug Administration (FDA) on Wednesday issued an immediately effective frequently asked questions guidance  explaining its approach to inspections and manufacturing and supply chain changes during the coronavirus disease (COVID-19) pandemic.   Inspections   For the time being, FDA says it is still following the approach to resuming domestic inspections it laid out last month and will continue to postpone non-mission-critical foreign pre-approval an...
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    FDA looks to resume domestic inspections this month

    Months after halting most inspections amid the coronavirus disease (COVID-19) pandemic, the US Food and Drug Administration (FDA) on Friday said it plans to resume on-site domestic inspections beginning the week of 20 July 2020.   As a safety measure, FDA will pre-announce all inspections, save for retail tobacco inspections, for the foreseeable future.   The announcement comes nearly two months after the agency said it will implement a phased approach to restartin...
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    PIC/S Opens Consultations on Manufacturing ATMPs, Biological Medicinal Substances

    The Pharmaceutical Inspection Co-operation Scheme (PIC/S) is seeking comments on revisions to two parts of its GMP Guide (Annex 2A and Annex 2B) that deal with the manufacture of advanced therapy medicinal products (ATMPs) and biological medicinal substances and products for human use. PIC/S explains that draft Annex 2A accounts for international developments in the regulation of ATMPs, with particular attention to the European Commission guideline on GMP for ATMPs, whi...
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    Grassley Calls for More Unannounced Foreign Drug Inspections From FDA

    As the US Food and Drug Administration (FDA) explores plans to lower the cost of pharmaceuticals with imports from Canada and elsewhere, Sen. Chuck Grassley (R-IA) is calling on the agency to perform more unannounced inspections of foreign facilities. Thanks to recent media coverage (on  China and tainted blood pressure medicines  and another article on  generic drug manufacturing ) as well as a controversial new book on the US reliance on foreign-made generic medicin...
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    FDA Warns Five Homeopathic Product Manufacturers for GMP Violations

    The US Food and Drug Administration (FDA) on Tuesday released warning letters sent to five homeopathic product manufacturers because of significant good manufacturing practice (GMP) violations. For instance, four of the companies jointly manufacture and package Puriton Eye Relief Drops, which are labeled as homeopathic. But FDA said it tested multiple samples and found the eye drops were non-sterile, which could lead to an eye infection, and had a high pH level, which c...
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    FDA Drafts Guidance on Inspections of Medical Device Establishments

    The US Food and Drug Administration (FDA) issued draft guidance on Thursday to implement uniform processes and standards for FDA inspections of domestic and foreign medical device establishments. FDA has updated processes and standards for uniformity within and across inspections other than for-cause and to establish a standard timeframe for such inspections of device establishments. The uniformity in FDA investigators’ approaches to these inspections “may inform firms’...