Common FDA Inspection Violations
As a dietary supplement or food manufacturer, it is critical to be aware of the most common inspection violations noted by the FDA during a facility inspection. By being informed and implementing preventative measures, you can avoid costly fines and potentially harmful consequences. Here are some common inspection violations to be aware of.
Failure to establish and maintain appropriate records
One of the most common violations found by the FDA is a failure to establish and maintain appropriate records. Records are essential for ensuring that your products are safe and meet regulatory requirements. The FDA requires firms to maintain accurate records of production, processing, packing, distribution, and sales. Failure to maintain these records can lead to significant fines and penalties. To avoid this violation, you should establish and maintain a record-keeping system that is thorough and accurate. Make sure to train your staff on proper record-keeping procedures and implement a system for verifying that records are complete and precise.
Inadequate hazard analysis and risk assessment
Hazard analysis and risk assessment are critical components of your Food Safety Plan. By conducting a hazard analysis, potential hazards are identified in your production process in which controls must be developed to mitigate these risks. You must conduct a thorough and appropriate hazard analysis and risk assessment to avoid any violations or risk to your consumers. This process must involve a comprehensive evaluation of all potential hazards and the development of effective controls to manage these risks.
Lack of preventive controls
Preventive controls are measures that are taken to prevent potential hazards from occurring. These controls can include procedures for monitoring critical control points, establishing sanitation protocols, and implementing recall plans. In order to implement effective preventive controls, you need to develop written procedures for monitoring critical control points, establish effective sanitation protocols, and develop a recall plan that outlines the steps you will take in the event of a recall.
Poor sanitation practices
Poor sanitation practices are a significant violation that can lead to the contamination of your products. The FDA requires manufacturers to maintain a clean and sanitary environment to ensure the safety of their products. It is crucial to establish effective sanitation protocols including implementing a master sanitation schedule, training employees on proper sanitation procedures, and regularly monitoring the cleanliness of your facility.
Mislabeling
Mislabeling can occur when a product is labeled incorrectly, when the label does not provide accurate information about the product, or when required information is left off of the label. This can include incorrect nutrition information, allergen labeling, and country of origin labeling. To avoid this violation, it is essential to ensure that your product labels are accurate and current. This can include conducting regular label reviews, verifying the accuracy of your nutrition information, and verifying that your allergen labeling is correct.
Failure to establish appropriate supplier qualification procedures
The lack of proper qualification of suppliers, including contracted facilities, are violations cited frequently by the FDA. Firms must ensure all vendors used for the manufacture, packaging, holding, and distribution of Food or Dietary Supplement products practice proper cGMPs. This is true for both domestic and foreign suppliers. Firms that import components and or finished products must develop a Foreign Supplier Verification Program (FSVP) per product they import. Firms often miss proper development and implementation of FSVPs therefore it is essential firms properly qualify potential suppliers before using their services. For domestic suppliers, this includes a supplier qualification questionnaire as well as initial qualification audits of the supplier facilities.
By being aware of the most common inspection violations found by the FDA and implementing preventative measures, you can avoid costly fines and potentially harmful consequences. Make sure to establish and maintain accurate records, conduct a thorough hazard analysis and risk assessment, implement effective preventive controls, maintain a clean and sanitary environment, ensure that your product labels are accurate and up-to-date, and establish appropriate supplier qualification procedures.