Earlier this year, a pet food company issued a recall of its products after reports of animals becoming sick, allegedly, from consuming the company’s pet food.  Recalls and their role in ensuring food safety was addressed in a prior blog post.  Recently, that same pet food company was issued a warning letter from the FDA.  The warning letter addressed remaining concerns regarding the company’s food safety plans and measures to prevent contamination of its products in the company’s manufacturing plants.  For this company, the recall was just the beginning.  How does a manufacturer prove to the FDA and the public that the identified problems have been addressed so that future products are safe?

From the manufacturer’s perspective, what happens after a recall?  First, a recall will likely initiate an inspection of the manufacturer’s plant to determine where problems exist.  If problems are found during the inspection, the manufacturer will be given a Form FDA 483 which details the concerns identified during the inspection.  The inspector will discuss the Form 483 with management, and the manufacturer will be encouraged to respond, in writing, to the Form 483.  That written response should explain, in detail, all corrective actions the manufacturer plans to take or is taking to address the concerns identified in the Form 483.  The manufacturer should move quickly to implement all corrective actions.  It is very important that the manufacturer not only identify the corrective actions it is taking but also quickly implement those actions.  It is vitally important that the manufacturer create and keep documentation of all the corrective actions it is taking and the results of those actions.  That documentation is how the manufacturer will prove to the FDA that it is adequately addressing the problems identified in the Form 483.  Failure to adequately respond, including inadequate documentation of corrective actions, can lead to a warning letter.  A response to a Form 483 which fully documents corrective actions and demonstrates that identified concerns have been successfully addressed can help prevent further FDA action, including a warning letter, and even, potentially, legal actions such as injunctions and seizures.

The importance of complete documentation can’t be overstated.

So - what sort of documentation is needed?  It will depend on the concerns identified in the Form 483, but the most important consideration is thoroughness that demonstrates to the FDA that Good Manufacturing Practices are being followed and that the manufacturer has successfully addressed every concern raised by the inspectors.  For example, if corrective actions include things such as additional testing protocols; employee training on how to take test samples; more frequent sanitization of equipment; and/or additional hazard analyses being done on ingredients used by the manufacturer – what documentation should the response to the Form 483 include?  For whatever corrective actions the manufacturer creates to address the concerns identified in the Form 483, it is vitally important that the manufacturer document how it is implementing all those corrective actions.  Every piece of data, including new testing protocols, the results of those new testing protocols, records of employee training, new hazards analyses (along with all the information considered in the hazard analyzes), etc. – essentially every bit of data that demonstrates how the manufacturer is fully addressing the concerns identified in the Form 483 and implementing procedures to correct those concerns needs to be included in the manufacturer’s response.  

The importance of complete documentation can’t be overstated.  The warning letter issued by the FDA mentioned above noted that, 

You provided a detailed summary of the changes which you state will be standardized across all four facilities for incoming corn, wheat, barley, oats, and rice. However, your responses do not include sufficient information and supporting documentation for us to fully assess the changes. For example, it is unclear if you have provided employee training on the new [contaminant] test procedures or if you have begun utilizing the new [contaminant] test procedures, as no employee training records or test records demonstrating implementation of the new test procedures were included with your responses.

From the perspective of customer relations, recovery after a recall can be equally as challenging as responding to the FDA.  How does a manufacturer win back customer trust? As with the FDA, openness about corrective actions and a thorough, well-documented explanation which demonstrates that the new procedures will be successful in producing a safe product is key.  Manufacturers may face lawsuits related to their products.  News coverage of those lawsuits and how they are handled by the manufacturer can impact how potential customers view the company.  The company also needs to communicate to the public everything being done to make its products safe.  This may include information about changes the manufacturer has put in place, test results of the products, etc.  Statements from experts, such as food safety experts or veterinarians, who have investigated the manufacturer’s new procedures and/or tested its products and can attest to the results of their investigations can be helpful.

The framework for recovery after a recall requires careful attention to detail for both the FDA and customers.  Thorough documentation of every action taken to correct problems that could compromise food safety is vital.  Just as in the courtroom setting, evidence is required to prove your case.