FDA Inspections and Pest Control - Pallets too close to walls

[Schkund]

My question relates to inventory organization with relationship to the FDA and pest control, specifically, placement of racks and/or pallets against internal and/or external walls.

Background: My company contract-manufactures for multiple industries, including Class I medical devices. We don't dabble in pharma and our products are pretty low risk items; as a result, our facility has never been inspected by the FDA, despite several years of registration. A couple of our customers hire a third-party auditing company to perform annual surveillance audits to 21 CFR 820, cGMP, etc. Frequently this third party hires former FDA inspectors as auditors. Two separate auditors with the same FDA background have made the same comment; we shouldn't push pallets too close to the walls, as it obstructs the path of pests, who normally will stick close to the wall, and shoots them off into the production area. We've never had a finding on this matter, but having the same observation come up during our facility tour has made me curious.

Is this something that could come up as a finding in the event that we finally undergo an FDA inspection? If so, what FDA regulation are we not meeting?

 

[v9991]

Hope u have already referenced the 21 CFR part 211.; depending upon the observation, Observation on creating an space between pallet & wall could relate to ease-of cleaning- maintenance etc

Sec. 211.42 Design and construction features.
(a) Any building or buildings used in the manufacture, processing, packing, or holding of a drug product shall be of suitable size, construction and location to facilitate cleaning, maintenance, and proper operations.

Sec. 211.56 Sanitation.
(a) Any building used in the manufacture, processing, packing, or holding of a drug product shall be maintained in a clean and sanitary condition, Any such building shall be free of infestation by rodents, birds, insects, and other vermin (other than laboratory animals). Trash and organic waste matter shall be held and disposed of in a timely and sanitary manner.
(b) There shall be written procedures assigning responsibility for sanitation and describing in sufficient detail the cleaning schedules, methods, equipment, and materials to be used in cleaning the buildings and facilities; such written procedures shall be followed.
(c) There shall be written procedures for use of suitable rodenticides, insecticides, fungicides, fumigating agents, and cleaning and sanitizing agents. Such written procedures shall be designed to prevent the contamination of equipment, components, drug product containers, closures, packaging, labeling materials, or drug products and shall be followed. Rodenticides, insecticides, and fungicides shall not be used unless registered and used in accordance with the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 135).
(d) Sanitation procedures shall apply to work performed by contractors or temporary employees as well as work performed by full-time employees during the ordinary course of operations.

 

[Ajit Basrur]

v9991 is right.

Also refer FDA Wall Clearance Requirements For Warehouse

 

[Schkund]

Correct me if I'm wrong, but isn't Part 211 for pharmaceutical devices? We don't manufacture any pharmaceutical products (no products with active ingredients or anything that could otherwise be classified as a "drug"). We don't have any pharmaceutical products registered with the FDA, only Class I medical devices, and no combination products. I wouldn't think we would be required to meet Part 211 requirements, would we? Our products don't fall within its scope.

 

[Schkund]

Ajit, thank you for the attachment, that does provide some clarification. I'll delve into the attached forum discussion further.

 

[v9991]

Correct me if I'm wrong, but isn't Part 211 for pharmaceutical devices?
We don't manufacture any pharmaceutical products (no products with active ingredients or anything that could otherwise be classified as a "drug").

We don't have any pharmaceutical products registered with the FDA, only Class I medical devices, and no combination products.

I wouldn't think we would be required to meet Part 211 requirements, would we? Our products don't fall within its scope.

For the sake legality - true; but its difficult to argue just alone based on it.
But the response to be more based on assessment viz., pest-controls in facility; trends if any on pest/rodents; process taking care of any possible infestation; any requirements & controls at end with customer / manufacturer before its used/dispatched to market etc
besides the point, isn't it only a good practice to ensure "cleanability", pest/rodent control etc.

 

[Schkund]

Certainly, and our facility does have procedures for ensuring cleanliness as well as a third party to conduct pest control activities, which we review, but I guess my point is that I'm still not sure we would get an observation based on placement of our pallets near interior walls based on Part 211 requirements. If we aren't meeting an FDA regulation, I want to know what that regulation is to ensure there aren't other gaps I should be addressing. It seems to be a specific point brought up by former FDA inspectors, "nothing should be within 12 to 18 inches from interior walls"... where is this coming from? The forum that Ajit attached at least shows that I'm not the only one who is a bit confused by this specific requirement.

 

[v9991]

following are pertinent references. Hope this helps...
next search is about FDA embracing / endorsing the following approach...

2013 Pest Management Standards For Food Plants

2.2 Rodent Program-Interior Survey All areas of the plant interior shall be surveyed for rodents and conditions which may lead to rodent infestation. The following observations must be identified and documented using a diagram and/or notes:
• Open doors, gaps beneath doors, or other holes, gaps or cracks which could permit rodent entry
• Clutter, debris or other potential rodent harborage location
• Lack of 18-inch inspection aisle along walls
• Areas of rodent infestation based on sightings, droppings, harborage or other evidence
• Spillage or other potential food sources which could lead to infestation
• Storage practices which are conducive to rodent infestation

National Pest Management Association, Inc. 2009 Pest Management Standards for Food Plants

Plants should have an inspection aisle of at least 18 inches along walls

.

Do Your Own Establishment Inspection A Guide to Self Inspection for the Smaller Food Processor and Warehouse

z Are products stored on pallets and at least 18 inches away from the walls? It is important to leave space for inspection aisles so that rodent and insect activity can be seen more readily. You might consider painting a white line on the floor along the walls to indicate inspection aisles.

 

[Schkund]

Interesting.... perhaps the FDA considers these references a "best practice" for pest control. Clearly this inspection aisle is widely used in the food industry; I could see the FDA expanding these guidelines to pest control in general. Thank you so much for your help! I'm glad to have a direction to point my inquiries!

 

[Edward Reesor]

I'm not one to pick a fight or argue endlessly with an auditor, but I am confident that "best practices" in one industry does not always translate to "best practices" in others (or else that industry would be subject to those standards from the onset). Does this infer that the food industry would then be expected to conform to specific best practices applied to Class I medical devices? This is the very reason why there are so many standards spread across so many industries.

Unless the auditor can site the standard that applies to the Class I medical device manufacturer being audited, I would dispute the NC to the head office and (if need be) request an auditor who is more familiar with the industry they are auditing.