enforcement
FDA has posted 20 Form 483 inspection records (see below), including reports involving Novo Nordisk, AnaptysBio, Protagonist Therapeutics, Ascendis Pharma and Charles River Laboratories, as the agency continues expanding public access to inspection findings through its electronic reading room. Their availability is part of the agency’s expanded transparency initiative
Drugs
FDA associate commissioner for inspections and investigations Elizabeth Miller says unannounced drug inspections in China and India increased significantly in FY 2026 compared with FY 2025 inspection numbers. As reported by the Regulatory Affairs Professional Society’s online Regulatory Focus newsletter, she spoke at the Association for Accessible Medicines’ GRx+
enforcement
FDA 11/5 posted five additional Form FDA-483 inspection reports, including four involving manufacturers in Japan and one involving a U.S. drug outsourcing facility. The newly published records cover inspections conducted between October 2023 and September 2026. They include: * LeeSar Inc., Florida: Inspection dated September 23, 2026, involving
Drugs
FDA has issued Vanda Pharmaceuticals an untitled letter citing a television advertisement for its motion sickness drug Nereus (tradipitant), alleging that a high-speed car chase and other dramatic scenes misleadingly portray the drug's effectiveness and safety while interfering with viewers' understanding of its risks. The agency
enforcement
FDA referenced artificial intelligence in just seven of 3,011 Warning Letters issued between 1/2022 and 9/28/2026, with only one letter explicitly identifying a company's use of AI as a regulatory violation, according to a new study published in Discover Pharmaceutical Sciences. The retrospective analysis,
Drugs
FDA says Amneal Pharmaceuticals of New York, in Brookhaven, NY, has been using unapproved Red #2 and Red #3 color additives in the manufacturing of prescription drugs. A just-released 10/27 Notice of Violation says the agency found the violations in its review of Amneal records that FDA requested
Drugs
FDA says its review of records and products submitted by Guangdong Bangze Medicine Co., Ltd., in Guangdong Sheng, China, in response to an agency 1/20 request, determined there were significant violations of current good manufacturing practice (CGMP) regulations for finished drugs in the firm’s production of over-the-
Drugs
A 6/2-6/6 FDA inspection at the Pritam International Private Limited drug manufacturing facility in Uttarakhand, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 10/27 Warning Letter says the agency also determined that the firm contract manufactures an over-the-
enforcement
FDA's stepped-up enforcement against prescription drug advertising may be having an unintended consequence: Some pharmaceutical companies are becoming more willing to accept promotional risks because the agency has issued so many enforcement letters without consistently escalating to more serious actions, attorneys said during a recent Food and
enforcement
FDA's anticipated proposal to restrict direct-to-consumer (DTC) prescription drug advertising could face significant statutory and First Amendment challenges, while changes in agency leadership raise questions about whether the administration's advertising enforcement campaign will maintain its momentum, attorneys said during a recent FDLI conference panel.
enforcement
FDA has released 33 additional Form FDA-483 inspection reports on 10/30, covering drug and biologic manufacturers, medical device companies, and human tissue establishments in the U.S. and overseas. The newly disclosed records include inspections of Baxter Healthcare, Catalent Maryland, Andelyn Biosciences, Charles River Laboratories, Autolus, AGC Biologics,
enforcement
Medical device manufacturers increasingly using artificial intelligence (AI) for quality assurance and regulatory functions must maintain human oversight of those systems, according to former senior FDA officials who say the agency is also beginning to incorporate AI into its inspection and postmarket surveillance activities. Speaking on the 10/26 FDA
FDA Policy/General
HHS has announced an interim enforcement-discretion policy allowing state-licensed pharmacies, federal facilities and licensed physicians to compound six previously restricted peptides under specified conditions while FDA considers whether to formally authorize their use under Section 503A of the Federal Food, Drug, and Cosmetic Act. The 10/28 policy
enforcement
FDA published another 33 Form 483 inspection records on 10/27 through its Office of Inspections and Investigations FOIA Electronic Reading Room, including records involving Catalent, Janssen Biopharmaceuticals, Ferring Microbiome, Genzyme, Philips Medical Systems, Baxter and Grifols. Their availability is part of the agency’s expanded transparency initiative (see earlier
Drugs
FDA has issued a Warning Letter to Amgen over a promotional video for its colorectal cancer drug Vectibix (panitumumab) because it omitted all safety information and failed to disclose important limitations on the drug’s approved uses. In the just-posted 8/12 Warning Letter, CDER’s Office of Prescription
enforcement
FDA published another 79 Form 483 inspection records on 10/26 through the Office of Inspections and Investigations FOIA Electronic Reading Room, continuing a series of substantial disclosures of previously unavailable inspection documents. Their availability is part of the agency’s expanded transparency initiative (see earlier story), but a significant
enforcement
FDA has released the 10-page Form FDA-483 issued following a 6/10-6/19 inspection at the Eugia Steriles Private Limited sterile drug product manufacturing facility in Andhra Pradesh, India. The five inspection observations were: * failure to establish and follow written procedures designed to prevent microbiological contamination of
enforcement
FDA has released the Form FDA-483 issued following a 2/19-2/27 inspection at the GSK Vaccines licensed biological drug manufacturing unit in Marburg, Hassia, Germany. The two inspection observations were: * failure to validate the cleaning procedures for dedicated equipment used in the manufacture of aluminum hydroxide adjuvant
Drugs
A 5/26-5/29 FDA inspection at the Northland Nuclear Medicine drug manufacturing facility in Bismarck, ND, found repeat current good manufacturing practice (CGMP) violations in the firm’s production of positron emission tomography (PET) drugs. A 10/22 Warning Letter says the firm’s PET drugs are adulterated
Drugs
An FDA review of records requested from Sanrace Biotechnology Co. in Zhejiang Province, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 10/22 Warning Letter says the specific violations were: * failure to conduct at least one test to verify the identity of each
enforcement
FDA has begun releasing large batches of Form FDA-483 inspection reports under its expanded transparency initiative (see earlier story), but a significant limitation in the agency's online FOIA Electronic Reading Room makes it difficult for users to identify newly posted documents: the database does not allow records
enforcement
FDA has accelerated the public release of Form FDA-483 inspection records as part of its expanded transparency initiative (see earlier story), increasing the volume of inspection documents available through the agency's FOIA Electronic Reading Room. On 10/23, the agency published 26 Form FDA-483 records covering