Montgomery County cities: 24 companies received FDA inspections in 2025

Kyle Diamantas, J.D., Deputy Commissioner for Human Foods of FDA
Kyle Diamantas, J.D., Deputy Commissioner for Human Foods of FDA
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There were 24 companies in cities associated with Montgomery County, Maryland, that received 24 FDA inspections in 2025, according to the U.S. Food and Drug Administration (FDA).

This is a 27.3% decrease from the number of companies inspected in the previous year, when 33 companies received 36 inspections.

Most of the companies inspected at the time operate in the Biologics sector. The second most common type of company inspected period worked in the Drugs sector.

There were 18 companies in line with FDA regulations who don’t need to adjust their management operations or regulatory/administrative actions (75%). Five should take voluntary action to correct the organization’s management operations (20.8%). Additionally, one company had to take regulatory and/or administrative actions (4.2%).

The FDA routinely inspects facilities across the nation to determine if the workplace and their products are compliant with FDA-regulated laws and regulations implemented to improve overall public health. Inspection results are then disclosed publicly.

According to its website, the FDA is a government agency that is primarily responsible for monitoring the production and distribution of human and animal drugs, biological products, medical supplies and tobacco products for safety and quality.

Companies Located in Cities Within Montgomery County and Their Inspection Results
Company Name Area of Business Inspection Date Result
Asefa J. Mekonnen, M.D. Biologics 04/17/2025 No Action Indicated (NAI)
ChiRhoClin, Inc. Drugs 09/15/2025 Voluntary Action Indicated (VAI)
GCDMV, LLC Food and Cosmetics 07/21/2025 No Action Indicated (NAI)
Human Genome Sciences, Inc. Drugs 07/31/2025 Voluntary Action Indicated (VAI)
Jonathan B. Cohen, M.D. Biologics 08/11/2025 No Action Indicated (NAI)
Laura Tonnetti, Ph. D. Biologics 11/21/2025 No Action Indicated (NAI)
Lawrence J. Green, M.D. Drugs 12/12/2025 No Action Indicated (NAI)
Longhorn Vaccines And Diagnostics, LLC Devices 10/30/2025 Official Action Indicated (OAI)
Lung Bioengineering, Inc. Devices 05/06/2025 No Action Indicated (NAI)
Maxim Biomedical, Inc. Biologics 05/07/2025 No Action Indicated (NAI)
NIH Donor Center at Fishers Lane Biologics 03/06/2025 No Action Indicated (NAI)
National institutes of Health Clinical Center Biologics 01/21/2025 No Action Indicated (NAI)
Otsuka Pharmaceutical Development & Commercialization, Inc. Drugs 07/18/2025 No Action Indicated (NAI)
Peruvian USA Distribution, LLC Food and Cosmetics 05/05/2025 No Action Indicated (NAI)
Precigen, Inc. Biologics 04/15/2025 No Action Indicated (NAI)
REGENXBIO, Inc. Biologics 07/31/2025 No Action Indicated (NAI)
Rapa Therapeutics, LLC Biologics 06/02/2025 Voluntary Action Indicated (VAI)
Rebecca A. Kazin, M.D. Devices 09/25/2025 No Action Indicated (NAI)
Robert E. Litman, M.D. Drugs 03/04/2025 No Action Indicated (NAI)
Scott M. Norberg, D. O. Biologics 04/23/2025 No Action Indicated (NAI)
Supernus Pharmaceuticals, Inc. Drugs 07/31/2025 No Action Indicated (NAI)
Vemulkonda K. Rao, M.D. Drugs 10/29/2025 Voluntary Action Indicated (VAI)
Wearlinq, Inc. Devices 11/26/2025 Voluntary Action Indicated (VAI)
William R. Childs, M.D. Biologics 09/26/2025 No Action Indicated (NAI)

Information in this article was obtained from the U.S. Food and Drug Administration. The source data can be found here.



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