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?
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?