FDA 3511-2 2010-2024 free printable template
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Firm Name, City & State: Inspection Date(s): Investigators: DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION FEI Number: FCE Number: FDA ACIDIFIED FOOD INSPECTION REPORT This inspection
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How to fill out fda acidified food 3511a
How to fill out FDA acidified food 3511a?
01
Carefully read the instructions provided with the FDA acidified food 3511a form.
02
Begin by providing your company's name, address, and contact information in the designated fields.
03
Fill in the product information section, including the name, code, and description of the acidified food product.
04
Indicate the process employed for acidification, including details such as pH levels and acid types used.
05
Provide information about the containers or packaging materials used for the acidified food product.
06
Specify any additional ingredients or additives included in the product.
07
Include the planned distribution and intended use of the acidified food product.
08
Attach any required supporting documents or certifications, as indicated on the form.
09
Review the completed form thoroughly for any errors or omissions before submission.
Who needs FDA acidified food 3511a?
01
Companies or individuals involved in the production, packaging, or distribution of acidified food products.
02
Acidified food processors who are required to comply with the regulations of the Food and Drug Administration (FDA).
03
Entities seeking to maintain compliance with the Code of Federal Regulations pertaining to acidified foods.
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What is fda acidified food 3511a?
FDA Acidified Food 3511a is a regulation issued by the United States Food and Drug Administration (FDA) that establishes standards of quality for acidified foods. The regulation requires acidified food manufacturers to process the food under specific pH and temperature requirements, and also requires them to submit a process filing to the FDA. Additionally, the regulation requires acidified food manufacturers to implement quality control procedures, such as testing the finished product and monitoring the production process.
How to fill out fda acidified food 3511a?
To fill out FDA Acidified Food 3511a, you will need to provide the following information:
• Product Name
• Product Description
• Processing Method
• Ingredients
• pH
• Water Activity (aw)
• Product Form
• Product Size
• Acidifying Agents
• Thermal Processing
• Critical Factors
• Records and Documentation
• Labels
What is the penalty for the late filing of fda acidified food 3511a?
The FDA has not published any specific penalties for filing Form 3511A late. However, failure to comply with FDA regulations can result in civil and criminal penalties, including fines and/or imprisonment.
Who is required to file fda acidified food 3511a?
Food manufacturers who process and pack acidified foods are required to file FDA Form 3511a, also known as "Registration of Food Canning Establishment" with the U.S. Food and Drug Administration (FDA). This form is specifically for acidified food processes and must be filed by the establishment engaged in the commercial processing and packing of acidified foods.
What is the purpose of fda acidified food 3511a?
The purpose of FDA Acidified Food 3511a is to ensure the safety and quality of acidified foods in the United States. Acidified foods are significantly acidic foods that have a pH value of 4.6 or lower and are commonly packaged in hermetically sealed containers. The FDA regulates acidified foods to prevent the growth of harmful bacteria, particularly Clostridium botulinum, which can cause botulism. This regulation (FDA Acidified Food 3511a) outlines the specific requirements and procedures for acidified food manufacturers, including guidelines for processing, record-keeping, labeling, and registration.
What information must be reported on fda acidified food 3511a?
When reporting on FDA Form 3511a for acidified foods, the following information must be included:
1. Complete identification of the firm, including name, address, and phone number.
2. Product name and description, including brand name and specific variety or flavor.
3. Container size and type, such as glass jar, tin can, or plastic bottle.
4. Manufacturing process description, including steps for acidification, processing, and packaging.
5. Exact formulation, including the type and quantity of each ingredient used.
6. pH values at which the finished product is held, or target pH values if below 4.6.
7. Method of pH control, such as the use of ingredients or processing techniques.
8. Heat processing parameters, including temperature, time, and method used (e.g., hot fill, retort).
9. Container closure details, such as type of closure, material, and method of application.
10. Scheduled process, which is a detailed description of the thermal processing method, including a reference to a specific process authority or scientific basis.
11. Date of manufacture and lot code/number for traceability purposes.
12. Storage and distribution conditions, including recommended temperature and duration limits.
13. Expected shelf life or expiration date of the product.
It is important to note that this list may not be exhaustive and additional information required by the FDA should also be provided as necessary. The specific regulations and requirements for reporting acidified foods can be found in the Code of Federal Regulations Title 21, Part 108 and 114.
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