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Accelerating ScienceThe Connected Lab / Biopharma / FDA Urges Companies to be ’Recall Ready’

FDA Urges Companies to be ’Recall Ready’

By 03.09.2022

The U.S. Food and Drug Administration (FDA) recently finalized guidance to help companies prepare for voluntary product recalls.  The guidance, called Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C, outlines the steps companies should take to develop recall policies and procedures before a recall is necessary. With a focus on training, planning and record-keeping, recall-ready companies can quickly and effectively remove violative products from the market and limit the public’s exposure to risk. 

A voluntary recall is an action taken by a company to correct a violative product or remove it from the market. A recalling company may act on its own initiative or the FDA may inform the company that a distributed product violates the law and recommend the company recall the product. The FDA has the authority to require recalls of certain products in particular circumstances, such as controlled substances, biological products, human cells, tissues and cellular and tissue-based products, medical devices and foods. 

“Voluntary recalls continue to be the fastest, most effective way for a company to correct or remove violative and potentially harmful products from the market to help keep consumers safe,” said Associate Commissioner of Regulatory Affairs Judith McMeekin, Pharm. D. “It is critical that all companies in the supply chain are ‘recall ready’ to ensure appropriate actions are taken swiftly across the distribution channels to best protect public health and the integrity of the supply chain. We will continue to work with companies to improve their recall procedures and minimize Americans’ exposure to potentially harmful products.”   

The new guidance explains how proper product coding and distribution records help facilitate faster, more accurate recall actions. It encourages recalling companies to use electronic communications to quickly identify and provide certain product information when alerting consignees and the public about a voluntary recall. 

Digital solutions help achieve recall readiness

How LIMS can help with recall readiness

Laboratory information management systems (LIMS) are a vital tool in achieving recall readiness.  Incident management capabilities like those found in Thermo Scientific™ SampleManager LIMS™ software help companies quickly identify and investigate product issues. When testing results are out of specification or out of trend, the solution automatically creates an incident for the result and notifies the user. Users can easily track the investigation in the system, including any additional samples tested. The system captures corrective actions and can link to an external investigation system. Results with open incidents are highlighted on the screen for easy identification.

Traceability of affected product in the production network is vital to minimize the impact of a recall. SampleManager LIMS software provides full traceability through lot and batch management functionality. In the event of a recall, LIMS enables fast traceability of all results and metadata from any suspect product back through all stages of production to initial ingredients test results. This enables operators to see which batches could be affected and take appropriate action.

The guidance also urges companies to act quickly to initiate a recall when public health is at risk and to do so prior to completing an investigation into the cause of the problem. Because recalls can affect the entire supply chain, including downstream suppliers, wholesalers or vendors, the FDA recommends that companies develop recall procedures to quickly inform their entire distribution chain, so consignees can rapidly identify affected lots and recall downstream products when necessary. 

Becoming recall ready

It is critical for firms in a product distribution chain to be “recall ready,” according to the FDA.  It recommends that a firm make the following general preparations in advance of a potential recall:

  •          Identify appropriate personnel
  •          Train personnel on their responsibilities
  •          Establish a recall communications plan
  •          Identify any reporting requirements for distributed products
  •          Use adequate product coding
  •          Maintain distribution records

For more details on bolstering your recall readiness, be sure to review Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C. 

michaelryan

Mike Ryan is a Product Marketing Manager at Thermo Fisher Scientific. His focus is defining digital connectivity solutions supporting the connected laboratory, accelerating scientific discoveries and streamlining lab operations.

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