What Form 483 means

After inspecting a food, drug, medical device, or biologic establishment, FDA prepares a written report of its inspection findings, following a debriefing. This report is intended primarily for internal FDA use and is not provided to the inspected institution at the conclusion of the on-site visit.

To provide the facility with its own written list of discrepancies noted during the inspection, FDA developed form FDA 483, “Notice of Inspectional Observations,” issued by the field investigator.

Form 483 should contain only those observations that can be directly linked to a violation of regulations—not suggestions, guidance, or other comments. Although the 483 does not contain references to the regulations, each observation should be directly traceable to a section of the applicable regulations.

Items placed on a form 483 are the opinion of the FDA investigator on the scene, and may be subject to review by others within FDA. Current FDA policy requires that the agency write a follow-up letter to clinical investigators and IRBs. When the items on the 483 are confirmed in that letter, they may be taken as an official FDA position. Conversely, there is no guarantee that the follow-up letter will be limited to the items listed on the 483, as additional review by FDA headquarters may identify significant regulatory violations that were not listed on the 483, which will be included in the follow-up letter.

Nevertheless, this does not mean that a 483 should be ignored. A recipient of a 483 should promptly respond to FDA. An effective response addresses each item, indicating agreement and either providing a timeline for correction or requesting clarification of what FDA requires.

Source: Applied Clinical Trials Online

2 Responses to What Form 483 means

  1. cwxwwwxdfvwwxwx says:

    well, hi admin adn people nice forum indeed. how’s life? hope it’s introduce branch😉

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