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

 

Introduction	Pg 1
Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers	Pg 1
Inspectional Authority	Pg 2
History of Emergency Permit Control and LACF Regulations	Pg 3
Emergency Permit Control	Pg 5
Establishment Registration	Pg 7
Process Filing Requirements	Pg 8
Process Adherence	Pg 9
Processing Authorities	Pg 9
Inspectional Considerations	Pg 11
Process Deviations	Pg 12
Detection and Correction In-Process	Pg 13
Reprocessing	Pg 13
Isolation of Affected Production	Pg 14
Submissions to Process Authorities	Pg 14
Incomplete Records	Pg 14
Issues Pertaining to Evaluation	Pg 15
Reporting Evaluation Results to The Processor	Pg 15
Better Process School	Pg 16
Forms	Pg 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

 

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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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