What’s the difference between a tire and a tin of tomatoes? Ok, a lot – especially when it comes to inventory storage and shipping requirements. Tomatoes, like all foods, skin products, medicines, vaccines, veterinary supplies and medical devices made or sold in the U.S., are regulated under stringent safety rules and guidelines set by the U.S. Food & Drug Administration for storage and shipping. The FDA is responsible for assuring the safety, efficacy and security of many human and animal products. For companies that sell these goods, FDA registered warehousing is essential to ensuring both regulatory compliance and customer confidence.

Recently, a new report indicates the global refrigerated warehousing and storage market (which includes blast freezing, tempering and modified atmosphere storage services) is expected to grow from $112 billion in 2020 to more than $164 billion in 2025. This growth is driven by several factors, including consumer demand for quality manufacturing and transparent sourcing, as well as companies restructuring their operations in response to the pandemic.

As longtime providers of FDA registered warehousing in Cleveland, we’re familiar with industry-wide efforts over the last decade to improve protections of temperature-controlled consumer products for packaging, processing and storage. Some measures have included onboarding better sensors, data logging and RFID devices. Not only does this help improve supply chain efficiency, it also helps reduce unnecessary losses and the potential for contamination.

Companies that make products requiring strict temperature controls and/or monitoring often outsource these responsibilities to 3PL warehousing companies for the benefit of operational costs, greater flexibility, improved efficiency and logistics expertise.

What is FDA Registered Warehousing?

The supply chain for products that are to be ingested, applied to the skin or given to animals rightfully must be more carefully regulated than those that don’t carry the same risks. Unless there is some specific exemption, owners/operators of any domestic or foreign food, drug or device facility must register with the FDA per the Food Safety Modernization Act. Basically, if your operation sells anything from first aid kids to chocolate, the FDA has oversight.

Warehouses that store, pack, repack, label and ship those items are also subject to FDA oversight. Registration requires a passing inspection every three years to verify the facility is complying with relevant regulations.

Why Should Your Warehouse be FDA Certified? 

Consumer product safety is imperative because it can directly impact the lives of people and animals. The slightest irregularity in temperature or other storage conditions can potentially compromise the health and well-being of consumers, leading to outbreaks, product recalls and diminished brand standing and more. Any company that sells FDA-regulated goods to consumers must ensure they protect those people and their profits by partnering only with properly-certified warehouses. This helps you avoid losses and liabilities and maintain quality control.

The technology we use for tracking and transparency also enables us to:

• Trace constituent parts and/or ingredients, as well as labor/equipment records involved in a manufacturing in case of a recall event.
• Track expiration dates to ensure those with the closest expiration lot date are shipped before newer lots.
• Identify exactly how much inventory is our location or in transit at any given time, how long it’s been there and under what precise conditions.

If FDA registered storage is central to your operations, On Time Delivery & Warehouse in Northeast Ohio has solutions to accommodate your unique product requirements and business model.

Contact On Time Delivery & Warehouse by calling (440) 826-4630 or sending us an email.

Additional Resources:

Refrigerated Warehousing and Storage Global Market Report 2021: COVID 19 Impact and Recovery to 2030, February 2021, Logistics and Freights Market Trends, ReportLinker

More Blog Entries:

Vaccine Distribution Highlights Cleveland Last-Mile Delivery Challenges, Jan. 25, 2021, Cleveland FDA Registered Warehousing Blog