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# FDA-483 Not a Proxy for Overall Quality: Califf
- URL: https://www.fdaweb.com/fda-483-not-a-proxy-for-overall-quality-califf/
- Published: 2026-03-31T12:00:00.000Z
- Updated: 2026-09-14T13:36:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160902

Former FDA commissioner **Robert Califf** says the form FDA-483 is the means by which an agency investigator notifies a firm that conditions were observed that may have violated the Federal Food, Drug, and Cosmetic Act. Writing in a *Clinical Leader* [column](https://www.clinicalleader.com/doc/the-much-feared-fda-form-0001?ref=fdaweb.com), he says the FDA-483 is too often used inappropriately as a proxy for overall quality of the firm to which it is issued.

A recent draft guidance “emphasizes again that FDA-483 is not a final FDA action (something that involves many contextual factors) and that in the response to the 483, the firm has the opportunity to resolve differences of opinion with the investigator and FDA team responsible for the inspection. Thus, using the 483 alone as a surrogate for overall quality could be very misleading,” Califf writes in the first of three articles he plans on the FDA-483.

He says the concept of identifying problems and correcting them in an explicit manner is a key component of modern quality systems. “The unfortunate use of form 483 as an isolated proxy for making blanket decisions about the overall quality of work does not serve this interest,” he concludes. “However, using it properly, as a tool to spur improvement in the quality of manufacturing and research and development, is to be encouraged.”