Phil Prain - Comment
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This is a Comment on the Food and Drug Administration (FDA) Other: Guidance for Industry: Questions and Answers Regarding Establishment, Maintenance of Records by Persons Who Manufacture of Records by Persons Who Manufacture, Process, Pack, Transport,Distribute Receive, Hold or Import Food (Edition 5)
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Comment
The document refers to a record keeping exemption for vertically integrated organizations that have the same ownership for warehousing, transportation, and retail locations.
Surely this is not the in the spirit of the FSMA. For example an organization that has 3 major central distribution centers and services several hundred retail locations with their own transport. It is highly likely that individual lots/batches of products will be received by the central distribution centers and be redistributed to a small portion of their retail locations. This would not facilitate an accurate and/or timely recall situation and worse still provide no reference for product that could be hazardous that has already been purchased through that retail location. Is there another overriding requirement that ensures that the final step prior to consumption can be identified at lot/batch level?
No documents available.
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Comment Period Closed
ID:
FDA-2011-D-0598-0003
Tracking Number:
1jx-83jt-9k60
Submitter Information
Country:
United States
State or Province:
FL
Category:
Private Industry - C0003
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