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Contents
Form FDA 483 (Highlighted sections in this Newsletter)
1.1 Header Information
1.2 Observations
1.2.1 Annotation
1.3 Signatures
1.4 Reverse Side
1.5 Addenda/Amendments
FDA Form 483
The content of the form may be handwritten, typed, completed in a PDF file and printed, or completed via the FDA's computer system.
Header Information
This section identifies
- the FDA district office that performed the inspection,
- the date(s) of inspection,
- the name and address of the facility that was inspected,
- the name and title of the individual to whom the 483 is issued to (usually the most responsible individual physically present in the facility),
- a brief description of the type of facility, and
- the facility's FEI (FDA Establishment Identification) number.
Observations
This section begins with a "disclaimer" that the form contains the observations of the inspector and does not necessarily "represent a final Agency determination regarding your compliance." Observations placed on a 483 are the opinion of the FDA investigator and may be subject to review by other FDA personnel. The full text is:
"This document lists observations made by the FDA representative(s) during the inspection of your facility. They are inspectional observations, and do not represent a final Agency determination regarding your compliance. If you have an objection regarding an observation, or have implemented, or plan to implement, corrective action in response to an observation, you may discuss the objection or action with the FDA representative(s) during the inspection or submit this information to FDA at the address above. If you have any questions, please contact FDA at the phone number and address above.
The observations noted in this Form FDA-483 are not an exhaustive listing of objectionable conditions. Under the law, your firm is responsible for conducting internal self-audits to identify and correct any and all violations of the quality system requirements."
The 483 then has a large area for recording the observations, which may be continued on several pages. The observations should be ranked in order of significance. If an observation made during a prior inspection has not been corrected or is a recurring observation, that may be noted on the 483.
The FDA will typically include only significant observations that can be directly linked to a violation of regulations - not suggestions, guidance, or other comments. ("Significant" is somewhat arbitrary and may be subject to the bias of a particular inspector.)
Observations of questionable significance should not be on the 483, but should have been discussed with the firm's management so that they understand how uncorrected problems could become a violation. The 483 will not normally include actual regulatory references.
Annotation
As of 1997, the FDA established an annotation policy for medical device inspections.
Editor's Note: This section is not covered in this series.
Signatures
The investigators' names are printed and signed, and the date of issue is recorded in this section. Titles for the investigators may also be included. If the 483 is multiple pages, the first and last pages have full signatures while the intervening pages are only initialed.
More next week.
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