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ENVIRONMENTAL REGISTER Illinois Pollution Control Board News No. 483June 1, 1994APPELLATE UPDATE FAILURE TO NAME A NECESSARY PARTY RESULTED IN DISMISSAL OF APPEAL The Fifth District appellate court
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To fill out Form 483, follow these steps:
02
Write the name and address of the person or company being inspected at the top of the form.
03
Fill in the date of the inspection and the name of the FDA investigator.
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Provide a brief description of the type of inspection being conducted.
05
Number each observation on the form, documenting any deviations or concerns found during the inspection.
06
Clearly state the specific regulation or requirement that is being violated for each observation.
07
Include any evidence or documentation supporting the observation, such as photographs or records.
08
Provide a recommended action plan to address each observation and bring the company into compliance.
09
Sign and date the form at the bottom to certify its accuracy.
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For more detailed instructions, refer to the official FDA guidelines or consult with an FDA representative.
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Form 483 is typically required by companies or individuals who undergo inspections by the U.S. Food and Drug Administration (FDA).
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It is used to report observations made during the inspection, including any deviations or violations of FDA regulations.
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The form serves as a notice to the inspected party and provides an opportunity for them to address and correct the identified concerns.
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These could include pharmaceutical manufacturers, food processing facilities, medical device manufacturers, and other FDA-regulated industries.
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Ultimately, anyone who falls under FDA scrutiny and is subject to inspections may need to fill out Form 483.
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