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LetterStream Provider of Critical Mail Services

LetterStream is a very effective tool for FDA recalls

Quick FDA Recall Overview

envelope with recall endorsement

If you are in a situation where your company needs to send out Certified Mail in compliance with FDA regulations, you've landed on the right page. Here you will learn how LetterStream can eliminate much of the pain and frustration that often accompanies this process.

The 5 steps of an FDA recall

  1. Initiation of a Recall. The initiation of a recall may be the result of a few different things: a voluntary action of your organization, a request by the FDA, or in certain situations the FDA will mandate a recall.
  2. Determination that the Action is a Recall. The FDA will formalize the recall process and strategy in conjunction with your firm.
  3. Notification and Public Warning. The FDA notifies the firm of necessary steps to notify the public and/or impacted individuals and/or organizations.
  4. Monitoring and Auditing the Recall. FDA develops and implements a recall audit program to ensure that the recall action has been effective.
  5. Termination of a Recall. FDA determines when a recall should be terminated and, upon such determination, provides written notification of termination to the recalling firm.

Is Certified Mail Required?

As you work through your recall strategy (step 2), the FDA and your company will work through the appropriate notification methods. Typically Certified Mail is required, but this will ultimately be determined by the FDA.

In the FDA Regulatory Procedures manual (2013), the FDA states:

"Recall communications should be sent in the most expeditious manner and commensurate with the hazard of the product being recalled, and, where appropriate, sent with proof of receipt (e.g., by certified mail). All communication methods related to the firm's recall should be documented accordingly."

Proof of receipt (while not spelled out clearly in FDA documentation) typically means a USPS Return Receipt/Green Card/PS Form 3811, or a USPS Electronic Return Receipt. Both methods result in a signature of the person, and the address that the letter was delivered to.

What else do I need to know?

If your recall involves a mailing of any kind, the FDA requests special wording on the outside of the envelope.

"Ensure that the recalling firm conspicuously marks the outside (e.g. the envelope) and the enclosed information (e.g., the recall letter or other type of message) of the recall communication "DRUG (or FOOD, BIOLOGIC, MEDICAL DEVICE, TOBACCO PRODUCTS, etc.) RECALL (or CORRECTION)." Additionally, the outside and enclosed information should be marked "URGENT" for all Class I and Class II recalls, and, when appropriate, for Class III recalls."

How do I get started?

You can get started with a phone call (1-888-501-5288) or email to LetterStream. We have performed numerous recalls via Certified Mail and can reduce the burden of what might already be a stressful situation

We can send your recall notices via USPS Certified Mail with or without return receipt and include the appropriate endorsements on the face of the envelope. In situations where First-Class mail is acceptable, we can assist in that area as well.

How fast can this happen?

We'd like to think that we are the fastest Certified Mail solution provider and can often mail your urgent Certified Mail in less than 24 hours. Please specify how quickly you need your mailing sent out when you contact us.

What if I have a lot of letters?

No need to worry, we can mail a whole lot of Certified Mail letters extremely quickly.

What if I have a complicated mail merge that needs to happen?

With our team of data experts we can deal with complex mail merge projects in order to get your mailing organized and out the door in short order.