Refusal of Inspection : More Details
If violations are discovered during the inspection, FDA inspectors will send a Form 483 to the factory at the closing meeting.
A list of findings made during the inspection can be found on form 483. At the closing conference, the inspector will consult and describe these findings to the supplier. A form 483, on the other hand, does not imply that the FDA has made a final decision about the facility’s GMP compliance.
Within 30 days of the inspection, the FDA will issue an Establishment Inspection Report (EIR). The FDA’s official assessment of a factory’s GMP compliance is reflected in the EIR.
Depending on the issues discovered during the inspection, the factory may be required to take additional action:
- If no violations were observed, no action was taken.
- When violations are discovered, but the issues do not warrant further regulatory action, voluntary action is suggested. In this case, improving GMP compliance is entirely optional.
- If violations discovered on-site necessitate additional administrative sanctions and mandatory corrective actions, official action will be taken.
- Organization and personnel
- Buildings and facilities
- Equipment and utensils
- Production and process controls
- Packaging and labeling
- Warehousing, storage and distribution
- Document and records controls
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