Get the free Form 483 - PharMedium Services, LLC - Producer of Sterile Drug Products. Form 483 - ...
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DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION DATE(S) DISTRICT ODOR.ESS AN PHONE N MINER 4040 North Central Expressway, Suite 300 Dallas, TX 75204 (214) 253-5200 Fax : (214)
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What is form 483 - pharmedium?
Form 483 - pharmedium is a form used by the U.S. Food and Drug Administration (FDA) to document and communicate inspectional observations from a regulatory inspection that could constitute violations of the Federal Food, Drug, and Cosmetic Act. It is used to notify the inspected establishment's management of objectionable conditions and practices found during the inspection.
Who is required to file form 483 - pharmedium?
The FDA is responsible for filing form 483 - pharmedium after conducting an inspection of a regulated establishment, such as a pharmaceutical manufacturer or distributor, including PharMedium Services, LLC (PharMedium).
How to fill out form 483 - pharmedium?
Form 483 - pharmedium is filled out by FDA inspectors during an inspection. It includes sections for documenting the observations, a classification of the observance, and an indication of whether the observation was corrected or not. The form is then provided to the establishment's management at the conclusion of the inspection.
What is the purpose of form 483 - pharmedium?
The purpose of form 483 - pharmedium is to alert the establishment's management about objectionable conditions and practices found during an FDA inspection. It serves as a tool to facilitate communication between the FDA and the inspected establishment to address and rectify regulatory violations and ensure compliance with applicable laws and regulations.
What information must be reported on form 483 - pharmedium?
Form 483 - pharmedium reports inspectional observations that could constitute violations of the Federal Food, Drug, and Cosmetic Act. This includes information about the observed objectionable conditions, practices, deviations from regulations, and any corrective actions taken or proposed by the establishment's management.
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