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Guide to Inspections of Low Acid Canned Food Manufacturers - 1

1

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



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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