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DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG Administration DISTRICT ADDRESS AND P ION ENE NUMBER DATE(S)Of INSPECTION 1431 Harbor Bay Parkway Alameda, CA 94502-7070 (520) 337-6700 Fax (510)
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Genentech Inc 483 is a form used by the U.S. Food and Drug Administration (FDA) to document and communicate inspection findings and violations of regulations during inspections of Genentech Inc facilities.
Genentech Inc is required to file the Genentech Inc 483 form when the FDA finds any significant violations or deviations from regulatory requirements during their inspections of Genentech Inc facilities.
To fill out the Genentech Inc 483 form, specific details of the inspection findings, violations, and deviations must be accurately documented. The form must also include the relevant dates, locations, and any corrective actions taken or planned by Genentech Inc.
The purpose of the Genentech Inc 483 form is to inform Genentech Inc management and FDA about inspections findings and violations. It serves as a formal notice for Genentech Inc to address the issues identified and take necessary corrective actions to ensure compliance with regulations.
The Genentech Inc 483 form should report the inspection findings, violations, and deviations from regulatory requirements. It must include details such as the specific regulations violated, dates, locations, observations made by the FDA inspector, and any corrective actions taken or planned.
The specific deadline for filing the Genentech Inc 483 form in 2023 is subject to the date of the inspection and the regulations set by the FDA. It is recommended to consult the FDA or legal experts to determine the exact deadline for filing.
The penalty for the late filing of the Genentech Inc 483 form can vary depending on the discretion of the FDA and the seriousness of the violations. It may result in additional regulatory scrutiny, fines, or other enforcement actions by the FDA.
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