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# FDA Posts 20 Form 483 Inspection Records
- URL: https://www.fdaweb.com/fda-posts-20-form-483-inspection-records/
- Published: 2026-11-12T17:45:59.000Z
- Updated: 2026-11-12T17:45:59.000Z
- Author: David McFarland
- Tags: enforcement

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](https://www.fdaweb.com/fda-unveils-transparency-roadmap-plans-more-disclosures/)), 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](https://www.fda.gov/media/196252/download?ref=fdaweb.com) |
| Pulsar Scientific LLC                                | May 6, 2026         | Massachusetts  | [Form 483](https://www.fda.gov/media/196269/download?ref=fdaweb.com) |
| Similasan AG                                         | Apr. 27, 2026       | Switzerland    | [Form 483](https://www.fda.gov/media/196257/download?ref=fdaweb.com) |
| KDC/ONE Socal Laboratories, LLC                      | Apr. 14, 2026       | California     | [Form 483](https://www.fda.gov/media/196255/download?ref=fdaweb.com) |
| Neva Analytics, LLC                                  | Apr. 1, 2026        | Colorado       | [Form 483](https://www.fda.gov/media/196254/download?ref=fdaweb.com) |
| Bora Pharmaceutical Laboratories Inc., Zhongli Plant | Mar. 27, 2026       | Taiwan         | [Form 483](https://www.fda.gov/media/196259/download?ref=fdaweb.com) |
| Nanovis LLC                                          | Mar. 19, 2026       | Indiana        | [Form 483](https://www.fda.gov/media/196270/download?ref=fdaweb.com) |
| Linemaster Switch Corporation                        | Mar. 6, 2026        | Connecticut    | [Form 483](https://www.fda.gov/media/196271/download?ref=fdaweb.com) |
| Wilber W. Su, MD                                     | Feb. 27, 2026       | Arizona        | [Form 483](https://www.fda.gov/media/196256/download?ref=fdaweb.com) |
| Orean Personal Care Ltd                              | Feb. 20, 2026       | —              | [Form 483](https://www.fda.gov/media/196260/download?ref=fdaweb.com) |
| Micro-X Ltd.                                         | Jan. 15, 2026       | Australia      | [Form 483](https://www.fda.gov/media/196263/download?ref=fdaweb.com) |
| 3B Medical, Inc.                                     | Dec. 10, 2025       | Ohio           | [Form 483](https://www.fda.gov/media/196268/download?ref=fdaweb.com) |
| Huons Co., Ltd                                       | Nov. 21, 2025       | South Korea    | [Form 483](https://www.fda.gov/media/196262/download?ref=fdaweb.com) |
| Sheffield Precision Medical Limited                  | Oct. 23, 2025       | United Kingdom | [Form 483](https://www.fda.gov/media/196265/download?ref=fdaweb.com) |
| Raptim Research Private Limited                      | July 25, 2025       | —              | [Form 483](https://www.fda.gov/media/196253/download?ref=fdaweb.com) |
| Fujifilm Medwork GmbH                                | Mar. 26, 2025       | Germany        | [Form 483](https://www.fda.gov/media/196266/download?ref=fdaweb.com) |
| Bioclinica Inc./Clario (eResearch Technology, Inc.)  | Feb. 27, 2025       | China          | [Form 483](https://www.fda.gov/media/195319/download?ref=fdaweb.com) |
| Genzyme Ireland Limited                              | Jan. 17, 2025       | Ireland        | [Form 483](https://www.fda.gov/media/188838/download?ref=fdaweb.com) |
| Swati Spentose Private Limited                       | May 31, 2024        | India          | [Form 483](https://www.fda.gov/media/196258/download?ref=fdaweb.com) |
| Synergy Health Ede BV                                | Oct. 12, 2023       | Netherlands    | [Form 483](https://www.fda.gov/media/196267/download?ref=fdaweb.com) |