enforcement

FDA Posts 18 Form 483 Inspection Records

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 (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 to be sorted by publication date.

Form 483 Records Published 11/6

Company / Establishment	Inspection date	FDA document
Charles River Laboratories	June 8, 2026	483
AnaptysBio	April 29, 2026	483
Novo Nordisk	April 17, 2026	483
Comparative Biosciences, Inc.	April 10, 2026	483
Protagonist Therapeutics Inc.	April 3, 2026	483
Ascendis Pharma LLC	March 6, 2026	483
Immuno-Mycologics, Inc.	March 5, 2026	483
Radiation Products Design, Inc.	March 4, 2026	483
Provisio Medical Inc.	February 27, 2026	483
Rogers Foam Corporation	February 25, 2026	483
Soma Technology Inc.	February 18, 2026	483
Kevin E. Miller, MD	February 13, 2026	483
Koven Technology, Inc.	February 6, 2026	483
Eduardo Patricio Yanez Ruiz, MD	January 22, 2026	483
Cardionxt	December 15, 2025	483
Superior Felt & Filtration LLC	December 5, 2025	483
Safesource Direct Glove Plant	December 5, 2025	483
Focalyx Technologies, LLC	December 1, 2025	483

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Form 483 Records Published 11/6

Read more

FDA Orders Eye Safety Warnings for All GLP-1 Drugs

FDA Probes Malignancy Risk Linked to Zolgensma Gene Therapy

Bias in Extension Studies Despite Their Value to FDA Safety Reviews: JAMA

Ex-HHS Aide Says Overton Pressured Makary Over Vaccine Approval