Form FDA 483

Form FDA 483 content OR 486

The content of a 483 may be handwritten, typed, completed in a PDF file and printed, or completed via the FDA's computer system called Turbo EIR.

Header information

The header identifies the FDA district office that performed the inspection, the date(s) of inspection, 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 starts 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 as follows:

"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 have 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. The investigator(s) should offer to annotate the 483 with one or more of the following:

1. Reported corrected, not verified.
2. Corrected and verified.
3. Promised to correct (may be appended with "by xxx date" or "within xxxx days or months").
4. Under consideration.

The actual annotation of the 483 occurs during the final discussion with the firm's management; if the firm prefers no annotation, then annotation will not be performed. The annotations may be after each observation, at the end of each page, or at the bottom of the last page prior to the investigator's signature(s).

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.

Reverse side

The reverse side of the form has this text:

"The observations of objectional conditions and practices listed on the front of this form are reported:

1. Pursuant to Section 704(b) of the Federal Food, Drug and Cosmetic Act, or 2. To assist firms inspected in complying with the Acts and regulations enforced by the Food and Drug Administration.

"Section 704(b) of the Federal Food, Drug, and Cosmetic Act (21 USC §374(b)) provides:

Addenda/amendments

It is possible that an error is discovered by the inspector(s) after issuing the 483. If the 483 was generated via Turbo EIR, then an amendment is created within that system. Else, an addendum is created. If possible, the investigator(s) will personally deliver the addendum/amendment to the firm.

Addenda/amendments are not normally used for adding observations to a 483 after the inspection has been closed out and the investigator(s) have left the premises.

Public access to Form FDA 483s

Form 483s are available under the Freedom of Information Act, but may be redacted to remove non-public information. The FDA publishes select 483s on their website at this location:

Some third parties query the FDA and publish a listing of Form FDA 483s issued since 2000.

As of 21-Nov-2009, the FDA is seeking input from the public "on whether inspection reports should be re-designed to separate out a summary or key findings page that could be made available to the public quickly." Responses from the public can be submitted on the FDA's web site.

Recent trends in Form FDA 483 observations

Tabulations of the most-cited issues tend to be relatively stable from year to year. FY2012 data compiled by FDA's CDER shows that these are the top three items of concern:

1. Procedures not written, or are not fully followed
2. Poor investigations of discrepancies or failures (CAPA)
3. Absence of written procedures

Tabulations of the most-cited citations were updated by the FDA for FY2013. Data from 2013 indicated the following 21 CFR 211 sections were cited. : These included: #211.22 Procedures not in writing, #211.192 Investigation of discrepancies, #211.100(a) Absence of written procedures, #211.160(b) Scientifically sound laboratory controls.