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# Attorney Sues FDA to Keep Name Off FDA-483
- URL: https://www.fdaweb.com/attorney-sues-fda-to-keep-name-off-fda-483/
- Published: 2023-05-17T12:00:00.000Z
- Updated: 2026-09-14T18:32:28.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5154479

In a “reverse-FOIA” case, an attorney who works for a company that is regulated by FDA and was inspected by the agency in 2022 filed suit on 5/16 in the DC federal court to block FDA from releasing the attorney’s identity in connection with the form FDA-483 that was scheduled to be published on 5/17\. The [suit](https://fingfx.thomsonreuters.com/gfx/legaldocs/jnpwyoazkpw/Cooley-lawsuit-FDA-2023-05-16.pdf?ref=fdaweb.com), which lists J. Doe as the attorney, says the agency intended to publish the FDA-483 “despite plaintiff’s detailed explanation to FDA as to why plaintiff’s identity should be redacted, given that the release of plaintiff’s identity is unnecessary, contrary to law, inconsistent with agency precedent, and harmful to plaintiff.”

The filing contends that releasing the plaintiff’s identity is an unjustified invasion of the individual’s personal privacy in violation of the Freedom of Information Act and the Federal Food, Drug, and Cosmetic Act. It also says that while the form FDA-483 observations are not a final agency determination of wrongful conduct by the company, they are presented like conclusions in an investigation report, “including inappropriate and unauthorized ‘observations’ about plaintiff,” and thus are likely to be publicly received as a final conclusion rather than initial, untested allegations.

The suit says the release of the attorney’s name “will cause irreparable harm to plaintiff’s professional reputation and livelihood as an attorney, as it will incorrectly and prematurely connect preliminary, inaccurate factual allegations against the company to plaintiff’s conduct. And it will do so with no valid benefit to the public whatsoever, given that plaintiff is an employee of a private company, not a government official, and there have been no final conclusions of any wrongdoing by plaintiff.”

The suit asks for temporary and permanent injunctions to prohibit FDA from publicly releasing the attorney’s name or information allowing the identification of the attorney in connection with any release of the form FDA-483.