Warning Letter Highlights the Importance of Process Validations

The FDA recently published a warning letter sent to a food manufacturer that processes/packages ready-to-eat (RTE) organic herbs, spices, dried fruit and peels, and dried vegetables.  Investigators found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation. The violations focused primarily on the facility’s supply chain preventive control program and the lack of validated process preventive controls at ingredient suppliers.  The manufacturer was also cited for not conducting a reanalysis of their food safety plan in response to new information about a hazard.

Manufacturers mitigate risk based hazards identified in their Food Safety Plan through the application of preventive controls at their suppliers, in their own facility, or by subsequent downstream processors.  The controls must be validated as part of the verification process.  The manufacturer in this case stated that microbiological hazards associated with spices were being controlled by ingredient suppliers with validated lethal processes.  However, the manufacturer did not maintain documentation that the spices purchased were treated with a validated process that provided a 5-log reduction in the target pathogen population.  Specifically, organic caraway seeds underwent a treatment as a preventive control for Salmonella, but a validation study indicating the parameters used to provide a 5-log reduction was unavailable for inspectors to review.

The manufacturer also outsourced processing of dried organic lemon peel to a third party for control of Salmonella.  However, the manufacturer did not verify that the treatment provided by the third party was validated to provide a 5-log reduction.  Additionally, third party audit results or validation studies were not maintained for a supplier of organic cumin and “vegmix”,  a mixture of carrot, garlic, onion, red bell pepper, and tomato granules.   

Manufacturers are required (by 21 CFR 117.170) to conduct a reanalysis of their food safety plan, or the applicable portion, whenever new information becomes known about potential hazards associated with a specific ingredient or food.  In this instance, the manufacturer was informed by a customer that ground organic parsley tested positive for the pesticide chlorpyrifos, a chemical hazard.  Currently, there is no tolerance for chlorpyrifos in parsley.  Pesticide hazards are typically controlled by the supplier of raw 
agricultural products such as parsley.  However, the manufacturer did not update and identify this pesticide or pesticides in general as a hazard requiring a supply-chain control in their hazard analysis.  The manufacturer’s justification for not considering pesticides as a hazard was that they only used organic suppliers.  However, due to the finding of chlorpyrifos, FDA indicated that consideration of pesticide hazards is warranted.

The warning letter is available on FDA’s website.  Deibel Laboratories is an industry leader, providing process validations for numerous clients.  For more information regarding process validations or food 
safety plan reanalysis, please visit our website.