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U.S. Department of Health and Human Services

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Volume IV - 2.15 Establishment Inspections

DFS Pyramid Logo

Orientation and Training

Food and Drug Administration

DOCUMENT NO.:

IV-02
VERSION NO.: 1.6

Section 2 - Microbiology

EFFECTIVE DATE:
10-01-03
REVISED:
05-02-14

 

Microbiologists are sometimes requested to accompany investigators on inspection of establishments that produce foods or drugs. The trainee will accompany an investigator and an experienced microbiologist. The investigator has the basic responsibility for an establishment inspection and the microbiologist is a technical advisor in matters pertaining to microbiology, but should participate fully in the inspection, noting items for the inspection report and final discussion with management. The investigator is in charge of the inspection.

Prior to inspection, the trainee should read pertinent parts of the Investigations Operations Manual (IOM), current edition, especially Chapter 1 Administration, Subchapter 1.6 - Public Relations, Ethics and Conduct; Chapter 4 Sampling, and Chapter 5 Establishment Inspection: Food.

Additional reading material includes the following:

  • 21 CFR Part 110 Current Good Manufacturing Practices in Manufacturing, Packaging or Holding Human Food
  • 21 CFR Part 113 Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers
  • 21 CFR Part 114 Acidified Foods
  • 21 CFR Part 123 Fish and Fishery Products
  • 21 CFR Part 111 Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements

The trainee should talk with the investigator, read the previous Establishment Investigations report (EIR), and read any Compliance Programs that apply. The trainee should also work closely with the senior microbiologist on preparation of sample collection materials and on proper protective clothing for the establishment.

2.15.1   Frozen, Chilled, Prepared Foods; Nutmeats; Shellfish

A. Objective

  1. To learn the procedures of inspection and sample collection.
  2. To complete a collection report (C/R).

B. Assignment

  1. During this inspection, the trainee will collect samples of raw materials, in line materials and finished product. 
  2. The trainee may analyze the samples collected.

C. Exercise

Working with the investigatory team, the trainee will assist in the following:

  1. Prepare a collection report.
  2. Contribute to the Establishment Inspection Report and evaluate if the report contained enough detailed evidence to support a recommendation for legal action. 
  3. Evaluate if the analytical results substantiated observations of insanitation.
  4. Evaluate if in line sub samples were sufficient to "point out" where bacterial contamination could enter the product.
  5. Discuss with the team what aspects of the inspection the trainee would like to improve or learn before the next inspection.

2.15.2  Canned Foods

A. Objective

This inspection is intended to familiarize the trainee with aspects of canned food manufacturing. There are common aspects to all establishment inspections regardless of the product manufactured. This inspection will enable the trainee to understand the common and the uncommon aspects.

B. Assignment

  1. The trainee will accompany an inspector and a microbiologist experienced in cannery inspections. 
  2. The trainee will collect samples during this inspection. 
  3. The trainee may analyze those samples collected, as appropriate. 
  4. When the EIR is written, the trainee should contribute to the final copy. The trainee will have made observations that can be valuable contributions. 

C. Exercise

Working with the investigatory team, the trainee will assist in the following:

  1. Prepare a collection report.
  2. Contribute to the Establishment Inspection Report and evaluate if the report contained enough detailed evidence to support a recommendation for legal action. 
  3. Help prepare the list of observations (Form FD 483) for presentation and discussion with Firm management.
  4. Evaluate if analytical results substantiate observations of insanitation or other problems such as seaming difficulties, poor quality raw materials.
  5. Discuss with the team what aspects of the inspection the trainee would like to improve or learn  before the next inspection.