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Save As... Save Data Print Next Page Previous Page Retrieve Data Email Form Reset Form DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION CONTRACT AUDIT FDA AUDITOR STATE INSPECTOR
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How to fill out contract audit - fda

01
Read the contract carefully and understand its terms and conditions.
02
Review any applicable regulations or guidelines from the FDA regarding contract audits.
03
Gather all relevant documents and information related to the contract.
04
Create a checklist or template to ensure all necessary information is included in the audit.
05
Follow a systematic approach to examine each aspect of the contract, including financial terms, performance obligations, and quality control measures.
06
Document any discrepancies or issues found during the audit process.
07
Prepare a comprehensive report summarizing the findings of the contract audit.
08
Communicate the audit results to the appropriate parties, such as management or legal departments.
09
Discuss any recommended actions or improvements based on the audit findings.
10
File and retain all audit documentation in accordance with record-keeping requirements.

Who needs contract audit - fda?

01
Companies or organizations that have contracts with the FDA.
02
Contractors or suppliers involved in the manufacturing, testing, or distribution of FDA-regulated products.
03
Entities seeking FDA approval or certification for their products.
04
Healthcare providers or facilities receiving funding or grants from the FDA.
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A contract audit - FDA is an examination of the records and activities of a FDA-regulated entity to ensure compliance with contractual agreements and FDA regulations.
FDA-regulated entities that have contracts with the FDA are required to file a contract audit with the FDA.
Contract audits - FDA can be filled out online through the FDA's designated reporting portal, following the instructions provided.
The purpose of a contract audit - FDA is to verify the accuracy of financial and performance data submitted to the FDA by regulated entities.
Contract audits - FDA must include details of financial transactions, compliance with contract terms, and any findings or discrepancies.
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