FDA Warning Letters

Services are offered globally to food and dietary supplement companies.

The FDA issues official Warning Letters to industry when it finds significant and/or ongoing concerns with products that can cause those products to be considered adulterated or otherwise unsafe for human consumption. FDA Warning Letters are generally issued following an unsatisfactory FDA inspection that causes the FDA to determine the products affected could lead to a food safety crisis such as an outbreak.

GFSS has 16 years of FDA experience working with food and dietary supplement companies who have received FDA Warning Letters.  GFSS is well-versed in knowing what changes need to be made to assure the FDA that your company is introducing products into the marketplace that are safe for human consumption.

GFSS offers the following services:

• Expert consultation with your company to determine the root cause of the FDA violations that caused the FDA to issue a Warning Letter to your company
• On-site mock audits and GAP analysis to help your company identify additional weaknesses in your food or dietary supplement safety management system
• Assist your company in determining the best course of corrective action
• Respond to the FDA on behalf of your company
• Act as your company representative in FDA matters