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U.S. FDA Food Agent

Description

U.S. FDA Food Agent Services
Must have U.S. Food Agent Agreement and Facility Registration selected to register,

Extended

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,

Fee

$450.00

Quantity:

Service

Food Facility Registration

Description

U.S. FDA Food Facility services $150.00 per year per facility.

Extended

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.

Fee

$150.00

Quantity:

Service

Food Facility Ammendments/Cancelations

Description

Food Facility Ammendments/Cancelations

Extended

Covers Ammendments, cancelations and third party verification for registration owner.

Fee

$99.00

Quantity:

Service

Quality Systems/CGMP Review

Description

Full CGMP or HACCP Review - Call for quotaion

Extended

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
    

Fee

$0.00

Quantity:

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