CGMP Compliant Facility

FDA Registered & cGMP Compliant Facility:

As a FDA Registered and cGMP (Current Good Manufacturing Practices) compliant fulfillment company, Jay Group is one of a small percentage of third-party-logistics (3PL) providers qualified to serve the needs of highly regulated industries including:

• Cosmetics (nail polish, hair care products, and perfumes)
• Personal Care Products
• Building Supplies (adhesives and paints, varnish, shellac, polish, and lacquer)
• Food and Beverages
• Nutraceuticals (supplements or dietary products)
• Medical Devices
• Medical and Healthcare Products (iodine, medicinal tinctures, rubbing alcohol, first aid kits, over the counter pharmaceuticals, thermometers, and other items containing mercury)
• Alternative Wellness Products (certain essential oils or CBD oil)

In order to serve these industries, Jay Group has put into place the procedures required to maintain strict quality control while safely storing, packing, and shipping FDA and cGMP protected products.

We are FDA registered to uphold the integrity of your brand.

FDA Registered Means:

Companies like Jay Group must meet strict process and quality standards to be registered with the FDA. The FDA is the federal agency charged with overseeing the safety of drugs, medical devices, food, cosmetics, and a number of other health-related products. This registration ensures that the registered company is able to provide the special care including tracking and monitoring fulfillment services that is FDA-mandated for food, drug, or cosmetic manufacturers and retailers.

We Are a cGMP Compliant Facility:

In addition to being FDA registered, Jay Group also provides cGMP compliant fulfillment. cGMP refers to the Current Good Manufacturing Practice regulations enforced by the U.S. Food and Drug Administration (FDA). cGMP is an internationally recognized system of quality control involved in every step of the manufacturing and delivery process (See 21 CFR §111.1). As a leading fulfillment company, Jay Group fully respects, understands, and follows the guidelines related to being both a FDA Registered company and a cGMP compliant facility.

cGMP Means:

Companies that are known as cGMPs and that are cGMP compliant demonstrate an ability to provide systems and processes that ensure the proper design, monitoring, and control of manufacturing processes and facilities needed to fulfill products in industries such as medical, food, drug (including supplements), cosmetics, and natural products. At Jay Group 3PL, we are fully committed to the safe and proper storage and shipping of cGMP-related products such as dietary supplements, vitamins, natural healthcare products, and other health and beauty products.

Quality & Compliance Related Services:

Jay Group’s internal Quality & Compliance Department supports the following FDA registration related services.

• Quarantine: Products can be quarantined systemically in anticipation of FDA on-site observation and inspection. Should additional measures be needed, Jay Group reserves secure caged areas for product storage.
• Recalls: When product recalls are required, Jay Group’s systems help track lot numbers, expiration numbers, and sales of recalled items. A quarantine of in-warehouse products that are affected by the recall can also be arranged.
• Climate Controlled: Temperature and humidity levels of each facility are strictly monitored and controlled.
• Proper Handling: Jay Group follows all FDA registration guidelines for proper handling of product.
• Inventory Management: Jay Group uses Manhattan Associates’ WMS to manage inventory at the case level. This means that every case is barcoded and contains the SKU information (including lot and expiration) for that case. Strict inventory management processes support the real-time tracking of lot numbers and expiration dates so that the “FIFO” (First In-First Out) or “FEFO” (First to Expire-First Out) approaches can be applied as required.
• Inspections: Jay Group offers both visual and manual inspection services that support compliance requirements.