“If you do get a warning, responding to the FDA with a plan for training and compliance will help your case,” said Simoneau. “It plays a factor in further action.”
The FDA recommends retailers take the following steps when they receive a warning letter:
— Review the letter carefully to see what charges are listed.
— Respond to the warning letter within 15 working days in writing, by mail or email. Include the following:
- An explanation of the steps that will be taken to correct the violation(s) and prevent future violations (for example, retraining, or removal of problematic items).
- Current contact information, including telephone number and email address.
— Promptly and adequately correct the violations listed.
There is no fine levied against a retailer for warning letters, but the FDA will usually make an unannounced follow-up inspection at the same retail store after a warning letter is issued to determine if the retailer took appropriate corrective actions.