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Briarcliff767
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Category: Legal
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Is there a specific FDA regulation requiring supply chain

Customer Question

is there a specific FDA regulation requiring supply chain traceability by vendors/manufacturers? I am a quality auditor for a biopharmaceutical company and trying to provide specific requirements for our vendor supply chain in accordance with FDA requirements.

Submitted: 6 months ago.
Category: Legal
Expert:  Briarcliff767 replied 6 months ago.
Hi my name is ***** ***** I am happy to assist you. Yes there is. I have gave you a link to this information and if you need further explanation or help please respond back . http://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/DrugSupplyChainSecurityAct/ucm427033.htmThanks
Customer: replied 6 months ago.
Hi. I am not seeing a clear requirement for vendors to provide full disclosure to their supply chain. I am a quality auditor for a biopharmaceuyical company and have been asked to provide reference to a specific regulation so that when we conduct audits, our vendors must provide for example, the exact manufacturing site of a material they provide if it comes from their supply chain.
Expert:  Briarcliff767 replied 6 months ago.
This tells you who must report please let me know if I am not understanding you correctlyhttp://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM426126.pdf
Customer: replied 6 months ago.

Is it The drug supply chain security act Section 582?

Expert:  Briarcliff767 replied 6 months ago.
it is