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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Low Acid Canned Food Manufacturers Part 1 - Adminstrative Procedures/Scheduled Processes

Guide to Inspections of Low Acid Canned Food Manufacturers - 1

 

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GUIDE TO INSPECTIONS OF 
LOW ACID CANNED FOOD MANUFACTURERS
Part 1-ADMINISTRATIVE
PROCEDURES/SCHEDULED PROCESSES

 

TABLE OF CONTENTS

IntroductionPg 1
Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed ContainersPg 1
Inspectional AuthorityPg 2
History of Emergency Permit Control and LACF RegulationsPg 3
Emergency Permit ControlPg 5
Establishment RegistrationPg 7
Process Filing RequirementsPg 8
Process AdherencePg 9
Processing AuthoritiesPg 9
Inspectional ConsiderationsPg 11
Process DeviationsPg 12
Detection and Correction In-ProcessPg 13
ReprocessingPg 13
Isolation of Affected ProductionPg 14
Submissions to Process AuthoritiesPg 14
Incomplete RecordsPg 14
Issues Pertaining to EvaluationPg 15
Reporting Evaluation Results to The ProcessorPg 15
Better Process SchoolPg 16
FormsPg 16

 

INTRODUCTION 

The Guide to Inspection of Low-Acid Canned Foods consists of three separate documents; Part 1 covers Administrative Procedures\Scheduled Processes; Part 2 covers Manufacturing Procedures; and Part 3 covers Container/Closures (Part 2 and 3 of the manual are still in process, and will issue at a later date). In addition to providing guidance for inspections of low acid canned foods (LACF) manufacturers, the guide also contains background and general information on LACF regulations and procedures.

In addition to the information and instructions provided in IOM Subchapter 530, 21CFR 108 and 113, and applicable compliance programs, direct attention to areas covered in this Guide when covering LACF manufacturers. Another good reference is the Food Processors Institute 'Canned Foods' manual, which should be available from anyone in your district who has attended a Better Process Control School.

At the current time DFI has available, for loan only, the following NFPA manuals:

1.Thermal Processes For Low-Acid Foods in Metal Containers (NFPA Bulletin 26-L)
2.Thermal Processes For Low-Acid Foods in Glass Containers (Bulletin 30-L)
3.Flexible Package Integrity Bulletin (Bulletin 41-L)
4.Guidelines for Thermal Process Development for Foods Packaged in Flexible Containers
5.Continuous Rotary Sterilizers-Design and Operation (Bulletin 44-L)
6.Automatic Control Guidelines For Aseptic System Manufacturers and Companies Using Aseptic Processing and Packaging for Preserving Foods (Bulletin 43L)

 

THERMALLY PROCESSED
LOW-ACID FOODS PACKAGED IN
HERMETICALLY SEALED
CONTAINERS 21 CFR 113 

Low-acid foods are defined as "any foods, other than alcoholic beverages, with a finished equilibrium pH value greater than 4.6 and a water activity greater than 0.85."

The following foods are not considered low-acid foods. Therefore, processors of these foods do not


 

1Note:  This document is reference materials for investigators and other FDA personnel.  The document does not bind FDA, and does not confer any rights, privileges, benefits, or immunities for or on any person(s).

 

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