How to choose an FDA registered warehousing partner

Seeking an FDA registered warehousing and order fulfillment partner for medical devices? Consider these high-priority capabilities while on your warehouse walkthrough tour:

• Lot traceability
• Labeling systems
• Medical device certifications

FDA REGISTERED WAREHOUSE CAPABILITIES YOU SHOULD KNOW

Sanitation and safety

Maintaining a clean and safe environment is essential for an FDA registered warehouse. Review your prospective partner’s pest control and cleaning procedures to ensure they meet and exceed your needs. Oftentimes, a walk of the warehouse perimeter will show whether the warehouse has become a target for rodents and pests.

A tour inside the warehouse will help guide your decision, too.  Are products properly shelved and labelled? An orderly warehouse is more easily maintained.

Labeling systems

An accurate labeling system is an absolute requirement for your FDA registered warehousing partner. Labels include important storage information, like temperature requirements, batch numbers, and expiry dates. Accurate labels help ensure that your products are following the “first in, first out” procedures required by the FDA.

For some pharmaceuticals and medical devices, labeling ensures clear chain-of-custody documentation as required by the FDA. When choosing your FDA registered warehousing partner, make sure you ask how their labeling system will help top-quality products reach your customers.

Lot control systems

Similar to labeling systems, lot control systems bring order and predictability to a warehouse full of an array of products. Lot control systems separate different brands, products, and batches from one another. For FDA regulated products, an effective lot control system will help mitigate the costs of potential quarantines and recalls. Ask your prospective FDA registered warehousing partner about their reverse logistics systems.

Receiving and dispatch

Your FDA registered warehousing partner should protect the quality of your product throughout the receiving and dispatching processes. Ask your prospective partner about how they protect inventory from the elements at their receiving and dispatch docks.

Climate-controlled warehousing

Warehouses and order fulfillment centers registered with the FDA must be clean, dry, and adaptable to the specific climate conditions required by the products it stores. Temperature and relative humidity records should be maintained for review. Ask your prospective FDA registered warehousing partner about their climate-control capabilities.

Medical device classifications

If you’re seeking a fulfillment warehouse for medical devices, ensure your prospective FDA registered warehousing partner is certified to handle Class I and Class II medical devices. Class II medical devices require additional labeling and tracking, so double check that your prospective warehousing partner’s labeling, lot control, and inventory management systems are up to snuff.

Security compliance

For highly regulated products, like pharmaceuticals, FDA registered warehouses will often comply with additional regulations enforced by the DEA. Proper security, including locks, alarms, and perimeter fencing, is common at many warehouses. Depending on the scheduling of a pharmaceutical, there may be additional personnel and secured storage areas required to store the drug. Ask your prospective FDA registered warehouse partner about their security protocols.

Trained personnel

A capable FDA registered warehousing partner will employ and train excellent personnel. All warehouse workers should be trained in good storage regulations and procedures, and they should be properly equipped with sanitary wear appropriate for the products they’re handling.

FIDELITONE: FDA REGISTERED 3PL PARTNER

FIDELITONE’s national network of FDA registered order fulfillment warehouses offer 1-2 day fulfillment to 98% of the population. With accurate inventory control systems and trained personnel FIDELITONE is a reliable FDA registered 3PL partner for food-grade warehousing, nutraceutical warehousing, medical device fulfillment, and more.

Doug Lindsay, FIDELITONE’s Corporate Compliance and Safety Manager, is responsible for maintaining current good manufacturing practices across FIDELITONE facilities. He ensures that FIDELITONE personnel and facilities are prepared to store, fulfill, and deliver your high-quality products.

“We strive to meet and exceed the highest standards of quality in FDA regulated warehousing,” says Doug. “We don’t just stop at the requirements set by the FDA. Our clients expect more—and we deliver more.”

Need help reducing costly waste from expiring inventory, ensuring maximum product performance and gaining the competitive advantage you need to maximize your profits? Contact us online or call (800) 475-0917 to ask about our FDA registered warehousing capabilities.