If regulatory non compliance observed during FDA inspection, the FDA inspector issues “Form 483” (Notice of Inspectional Observations) to the facility. The contents of the 483 comprise inspectional observations but do not represent a final Agency determination regarding compliance.
The company which receives a 483
should respond to the FDA addressing each item within 15 working days. A
response is not compulsory but a good response can help the company avoid
receiving a warning letter, or stronger enforcement actions including
withholding of product approval or even a plant shutdown.
FDA provides initial classification of the inspection based on
the observations noted during the inspection, the investigator’s report, and
FDA District Office supervisory personnel review. With the exception of
instances where procedures indicate that the relevant product center has the
right of final classification, the final classification of the inspection is
made by the FDA District Office. An inspection
classification reflects the compliance status of the establishment at the time
of the inspection, based on the observations documented. The conclusions of
the inspection are reported as Official Action Indicated
(OAI), Voluntary Action Indicated (VAI), or No Action Indicated (NAI).
An OAI inspection classification occurs
when significant objectionable conditions or practices were found and
regulatory action is warranted to address the establishment's lack of
compliance with statute(s) or regulation(s).
A VAI inspection
classification occurs when
objectionable conditions or practices were found that do not meet the threshold
of regulatory significance. Inspections classified with VAI violations are
typically more technical violations of the FDCA (The United States
Federal Food, Drug, and Cosmetic Act).
An NAI inspection classification occurs
when no objectionable conditions or practices were found during the inspection
or the significance of the documented objectionable conditions found does not
justify further actions.
If no enforcement action is contemplated, or after enforcement
action is concluded, FDA provides inspected establishments with a final inspection
report, called an Establishment Inspection Report (EIR), which
includes:
- Brief history of prior inspectional findings, including any action taken by FDA or corrective action taken by the firm in response to a previous inspection
- The investigator’s narrative report
- Any refusals, voluntary corrections, or promises made by the firm’s management
- Copies of forms
the FDA issued to the firm during the inspection, including the FDA Form
483.
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