enforcement

FDA Posts 20 Form 483 Inspection Records

FDA has posted 20 Form 483 inspection records (see below), including reports involving sterile drug manufacturer Huons in South Korea, Bora Pharmaceutical Laboratories in Taiwan, Genzyme Ireland, Similasan in Switzerland, and medical device manufacturers in the U.S. and overseas.

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.

Newly Published FDA Form 483s

Company	Inspection date	Location	FDA document
JOINN Laboratories (Suzhou) Co. Ltd	May 15, 2026	China	Form 483
Pulsar Scientific LLC	May 6, 2026	Massachusetts	Form 483
Similasan AG	Apr. 27, 2026	Switzerland	Form 483
KDC/ONE Socal Laboratories, LLC	Apr. 14, 2026	California	Form 483
Neva Analytics, LLC	Apr. 1, 2026	Colorado	Form 483
Bora Pharmaceutical Laboratories Inc., Zhongli Plant	Mar. 27, 2026	Taiwan	Form 483
Nanovis LLC	Mar. 19, 2026	Indiana	Form 483
Linemaster Switch Corporation	Mar. 6, 2026	Connecticut	Form 483
Wilber W. Su, MD	Feb. 27, 2026	Arizona	Form 483
Orean Personal Care Ltd	Feb. 20, 2026	—	Form 483
Micro-X Ltd.	Jan. 15, 2026	Australia	Form 483
3B Medical, Inc.	Dec. 10, 2025	Ohio	Form 483
Huons Co., Ltd	Nov. 21, 2025	South Korea	Form 483
Sheffield Precision Medical Limited	Oct. 23, 2025	United Kingdom	Form 483
Raptim Research Private Limited	July 25, 2025	—	Form 483
Fujifilm Medwork GmbH	Mar. 26, 2025	Germany	Form 483
Bioclinica Inc./Clario (eResearch Technology, Inc.)	Feb. 27, 2025	China	Form 483
Genzyme Ireland Limited	Jan. 17, 2025	Ireland	Form 483
Swati Spentose Private Limited	May 31, 2024	India	Form 483
Synergy Health Ede BV	Oct. 12, 2023	Netherlands	Form 483

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FDA Oncology Chief Details Staffing, Clinical Trial Modernization Efforts

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Modest Device Material Change May Need New 510(k): Post

Even seemingly modest medical device material changes such as new colorants, a different preservative, or a reformulated component sourced from a new supplier, may require submission of a new 510(k) to FDA. That’s the advice from principal medical device regulation expert Adrienne Lentz (Hyman, Phelps & McNamara) in

Newly Published FDA Form 483s

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NDA Filed for Zipalertinib in Lung Cancer

FDA Oncology Chief Details Staffing, Clinical Trial Modernization Efforts

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Modest Device Material Change May Need New 510(k): Post