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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Inspectional Observations and Citations

Observations are listed on a Form 483 in order of significance by the investigator.  The format of any single observation begins with a statement based in a citation of law, regulation or Act and is followed by a statement of specific conditions observed during the inspection. For a description of the citations and the data in the attached spreadsheets, please see A Short Description of Citations.

These fiscal year reports list the standardized citations, in decreasing frequency of use for TurboEIR system issued 483s, the first component of the 483 observations, the short and long plain language citations describing the laws, regulations or Acts and the CFR or other reference. There may be many citations for each CFR reference, addressing specific and distinct elements of the referenced law or Act.

As laws and regulations are frequently complex, identifying multiple areas for concern, the short description identifies the specific element which is objectionable for an observation. The long description and reference number provide context for a short description that is cited in an observation.

For examples of inspectional observations and how the standardized citations are used to record observations, please see the ORA Reading Room for examples of recently issued 483s.

 A Short Description of Citations

Citations are maintained in a database and are reviewed, edited and updated on a periodic basis. Citations relate to a Code of Federal Regulations (CFR) reference, and there may be many citations for a single CFR reference. To create an FDA Form 483, citations are selected from the pre-established system or database. The Long Description is entered into the FDA Form 483, ensuring uniformity of presentation, then specific information related to the observation may be entered, and the citations may be ranked by significance on the 483. At the present time, the citation database does not contain cites for all areas of the Food Drug and Cosmetic Act or the regulations enforced by FDA, so FDA Form 483’s that reference these are written manually and the citations are not be available for reporting from this database. 

 

In the fiscal year reports, a citation has the following display:

Example of an FDA Form 483 Citation

 

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