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.