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COMMONWEALTH OF PENNSYLVANIA STD-483 REV. 8/14 EQUAL EMPLOYMENT REVIEW CERTIFICATE POSITION INFORMATION 1. JOB TITLE OF POSITION BEING FILLED 2. POSITION NUMBER 3. EEO CODE/JOB GROUP 4. BUREAU/ORGANIZATIONAL
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How to fill out std-483
How to fill out std-483:
01
Start by obtaining a copy of the std-483 form. This form is used by the United States Food and Drug Administration (FDA) to document observations made during inspections of facilities that produce or handle FDA-regulated products.
02
Read the instructions carefully to understand the purpose of each section and the information required for completion.
03
Begin filling out the form by providing the name, address, and contact information of the facility that is being inspected.
04
Next, provide the date of the inspection as well as the identifying number assigned to it.
05
Proceed to the section of the form that requires you to list the observations made during the inspection. Clearly and concisely document each observation, providing sufficient detail to accurately convey the issue.
06
Include any relevant documentation or evidence to support each observation, such as photographs, test results, or samples collected during the inspection.
07
If applicable, provide references to any applicable regulations, standards, or guidelines related to each observation.
08
Make sure to sign and date the form once all observations have been recorded.
09
After completing the form, make copies for your records and submit the original to the appropriate FDA district office within the specified timeframe.
Who needs std-483:
01
Manufacturers: Any facility involved in the production, processing, packing, labeling, or holding of FDA-regulated products may be subject to inspections and therefore may need to complete std-483 forms.
02
Distributors: Facilities that handle the distribution of FDA-regulated products may also be subject to inspections and need to comply with the requirements of the std-483 form.
03
Importers: Companies that import FDA-regulated products into the United States may be inspected by the FDA, thus necessitating the need to fill out std-483 forms.
04
Laboratories: Testing laboratories that handle FDA-regulated products may be subject to inspections and need to complete the std-483 form if necessary.
05
Regulatory Compliance Professionals: Individuals responsible for maintaining regulatory compliance within a facility should be familiar with the std-483 form and its requirements to ensure proper completion when needed.
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