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Service
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U.S. FDA Food Agent
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Description
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U.S. FDA Food Agent Services Must have U.S. Food Agent Agreement and Facility Registration selected to register,
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Extended
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United States Agent Services
Assist Food Registration and Listing
Must have U.S. Food Agent Agreement and Facility Registration included in your cart to register,
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Fee
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$450.00
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Service
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Food Facility Registration
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Description
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U.S. FDA Food Facility services $150.00 per year per facility.
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Extended
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Assist with U.S. FDA Food facilities registration
Serve as your Regulatory Liaison in communicating with FDA Officials on behalf of you our client, regarding its product(s) for export to the U.S. Market
Provide up to date information to you regarding Compliance.
AGDE Corporation offers 24 hour / 7 day a week customer service.
Assist FDA and our clients coordinate Site Inspections.
Must have U.S. FDA Food Agent Agreement included in your cart to register.
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Fee
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$150.00
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Service
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Food Facility Ammendments/Cancelations
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Description
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Food Facility Ammendments/Cancelations
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Extended
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Covers Ammendments, cancelations and third party verification for registration owner.
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Fee
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$99.00
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Service
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Quality Systems/CGMP Review
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Description
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Full CGMP or HACCP Review - Call for quotaion
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Extended
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Services include full mock inspection by a certifed consultant. The API chemistry, manufacturing, and controls audit includes: * Quality Management * Personnel * Buildings and Facilities * Process Equipment * Documentation and Records * Materials Management * Production and In-Process Controls * Packaging and Identification Labeling of APIs and Intermediates * Storage and Distribution * Laboratory Controls * Validation * Change Control * Rejection and Reuse of Materials * Records and Reports * Recalls * Contract Manufacturers (Including Laboratories) * Agents, Brokers, Traders, Distributors, Re-Packagers and Re-Labelers
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Fee
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$0.00
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