レジストラ・コープのFDA登録管理サービス

Registrar Corp recommends having the following documents for this submission:

For the product:

• Product name, number and size of retail containers, batch and lot numbers, any product identification codes, IFN number (if previously notified to FDA)
• Countries in which currently marketed and duration
• Quantity intended to be introduced to US market (by weight).
• “Use by” date if in current inventory. If not in current inventory, the date you plan to introduce it into U.S. commerce. Indicate if it will be a one-time shipment or multiple shipments.
• Name and location of manufacturing facilities
• Distribution plan down to retail level, if available
• Full quantitative formulation, list of all ingredients, amount of each ingredient per absolute amount (such as mg/kg or g/L)
• Copy of the product label
• Description of the product packaging
• Summary of finished product testing results for most recent batch/lot at each facility:
  • Level of each nutrient required by 21 CFR 107.100
  • Level of any other nutrient added by the manufacturer in units per 100 kcal
  • Explanation of any deviation for a specialized formula that may not meet all requirements but is appropriate for dietary management of a specific disease or disorder
• For powdered formula, a summary of finished product testing results for the most recent batch/lot at each facility:
  • For Cronobacter : 30 samples, with each sample being 10 grams
  • For Salmonella : 60 samples, with each sample being 25 grams
  • Description of test method used and copy of the method (e.g., certificate of
    analysis with information listed in 21 CFR 117.165(b)(2) from a qualified laboratory)

For each manufacturing facility:

• Certification of established current GMP designed to prevent adulteration, including quality control procedures and in-process controls, and testing required under the cGMP
• Schematic diagram (i.e. process flow diagram) with processing times and temperatures, written narrative that includes a summary of process flow, heating and processing conditions, and critical control points
• FDA Food Facility Registration Number
• If facility has not received an FDA inspection:
  • Date of last inspection by the relevant government authority, or
  • Third party audit conducted by a qualified auditor on behalf of the government authority
  • Summary of the findings, standards/regulations against which the inspection was conducted, and any actions taken by the manufacturer in response