Bobby Wood's Food Storage System

FDA Inspections of Food Plants – Part 2 Inspectional Issues

 

 

Part 1 considered the inspection process. We now turn to the specifics of what FDA investigators generally focus on during a plant inspection.

 

Because there are no record keeping requirement in the umbrella CGMPs (21 CFR 110), investigators must rely entirely on can be observed directly or deduced from samples collected during an inspection, unless they demand records under the Bioterrorism Act of 2002 (www.fda.gov/oc/bioterrorism/Bioact.html). In the case of acidified and low-acid foods, they can supplement and support their observations from an examination of  the required records. In all cases, however, investigators are well trained to look, listen, and draw conclusions from what they see and hear. The following lists those things for which investigators typically “look and listen”. For more information, the reader is referred to the FDA Investigations Operations Manual, Subchapter 5.4 (www.fda.gov/ora/inspect_ref/iom/pdf/chapter5.pdf). The issues that follow are keyed to the relevant sections of the umbrella CGMPs.

 

110.10 Personnel

 

• Identity of owners, partners or officers, and management officials/employees involved in the inspection
• Attitude and actions of employees discharging their duties
• Employee dress and cleanliness
• Health of food-contact employees
• Unsanitary employee practices
• What employees tell the inspector
• Employee education and training

 

 

110.20 Plant and grounds

 

• Environmental factors that may contribute to rodent, bird, insect, or other sanitation problems
• Design and condition of buildings
• Toilet facilities
• Company attitude toward maintenance
• Waste and garbage disposal
• Methods for preventing waste materials from being mingled with raw materials
• Disposition of waste containing pesticide residues
• Removal of moisture (condensate) and oil from central compressed air supply
• Undrained loops in central compressed air supply
• Standing water

 

 

110.35 and .37  Sanitary operations, facilities, and controls

 

• Condition and appearance of the plant
• Cleaning and sanitizing materials and their storage
• Pest control program and effectiveness
• Cleaning sanitizing of food contact surfaces
• Adequacy of the water supply and plumbing
• Floor drainage
• Sewage disposal
• Hand-washing and toilet facilities
• Hand sanitizing stations in the manufacturing area
• Rubbish and offal disposal

 

 

110.40 Equipment and utensils

 

• Condition before processing begins
• Cleaning of filtering systems
• Sanitary condition of equipment
• Prior history and cleaning procedures for leased equipment
• Residue on conveyor belts
• Cleaning, sanitizing, and storage of cleaning implements
• Effectiveness of cleaning practices
• Placement of mercury thermometers and light bulbs
• Monitoring and replacement of UV lights
• Nature, frequency, supervision, and effectiveness of sanitizing practices

 

 

110.80(a) Raw materials

 

• Storage – pattern, rotation, housekeeping, accessibility for inspection, evidence of infestation
• Handling procedures
• Inspection practices
• Use of “Food Chemicals Codex” to assure the use of only food-grade materials

 

 

110.80(b) Manufacturing processes

 

• Whether and how hands and equipment are sanitized after contact with unsanitized surfaces
• Methods for re-using scrap materials – e.g. soaking or hand kneading – to protect from microbial contamination
• Ingredient handling — contamination with filth; effectiveness of cleaning and inspection operations prior to or while adding to the process; lags during the process
• Food additives — legal; restricted to legal amount; packaging materials and waxes or chemicals applied to fresh fruit excluded during routine inspections
• Color additives
• Quality control — inspection system; laboratory tests both on site and contracted; manufacturing code system

 

 

110.93 Warehousing and distribution

 

• How well the food is protected during storage and transportation

 

 

Daily meetings with the investigator provide an opportunity to learn early in the inspection if the investigator has observed any CGMP deviations. Any deviations that can be corrected before the inspection is finished should be and the correction shown to the investigator (more about this in Part 3.)

 

 

About the Author

Fred Hymes, Ph. D. has an extensive background in both general and quality management, and in the use of quality strategies to enhance performance through both breakthrough and long-term improvements. Prior to founding WFH Associates, Inc., Dr. Hymes was president and CEO of a small company; vice president, quality management of a multinational company; and general manager of a manufacturing and sales division of the same company.

WFH Associates, Inc. provides expert assistance and training in the use of quality strategies and sound, cost-effective regulatory compliance to improve costs and gain competitive advantage. We assist companies seeking to implement an operational excellence process, improve product and/or service quality, obtain ISO 9001 registration, improve regulatory compliance, or upgrade their quality systems. Specific expertise includes: quality management and continual improvement; drug, medical device, and food cGMP compliance; and ISO 9001, ISO/TS 16949, and ISO 13485 implementation. You may learn more about WFH Associates at http://www.wfhassociates.com/

Contact Dr. Hymes at http://www.wfhassociates.com/contact.php

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