The three Blue Bell “483’s” – FDA Inspection Reports are here:
Observation #1: Failure to manufacture and package foods under conditions and controls necessary to minimize the potential for growth of microorganisms and contamination.
Observation #2: Failure to perform microbial testing where necessary to identify sanitation failures and possible food contamination.
Observation #3: The procedure used for cleaning and sanitizing of equipment and utensils has not been shown to provide adequate cleaning and sanitizing treatment.
Observation #4: Failure to provide running water at a suitable temperature for cleaning equipment, utensils and food-packaging materials.
Observation #5: The plant is not constructed in such a manner as to prevent drip and condensate from contaminating food, food-contact surfaces, and food-packaging materials.
Observation #6: Employees did not wash and sanitize hands thoroughly in an adequate hand-washing facility after each absence from the work station and at any time their hands may have become soiled or contaminated.
Observation #7: Failure to store cleaned and sanitized portable equipment in a location and manner which protects food-contact surfaces from contamination.
Observation #8: All reasonable precaution are not taken to ensure that production procedures do not contribute contamination from any source.
Observation #9: The design of equipment does not allow proper cleaning and maintenance.
Observation #10: Failure to hold foods which can support the rapid growth of undesirable microorganisms at a temperature that prevents the food from becoming adulterated.
Observation #11: Failure to have smoothly bonded or well maintained seams on food contact surfaces, to minimize accumulation of food particles and organic matter and the opportunity for growth of microorganisms.
Observation #12: Failure to take apart equipment as necessary to ensure thorough cleaning.
Observation #1: Failure to manufacture foods under conditions and controls necessary to minimize the potential for growth of microorganisms.
Observation #2: The procedure used for cleaning and sanitizing of equipment has not been shown to provide adequate cleaning and sanitizing treatment.
Observation #3: The plant is not constructed in such a manner as to prevent condensate from contaminating food and food-contact surfaces.
Observation #4: Failure to clean food-contact surfaces as frequently as necessary to protect against contamination of food.
Observation #5: Failure to wear beard covers in an effective manner.
Observation #6: Failure to maintain buildings in repair sufficient to prevent food from becoming contaminated.
Observation #1: Failure to perform microbial testing where necessary to identify possible food contamination.
Observation #2: Suitable outer garments are not worn that protect against contamination of food and food contact surfaces.
Observation #3: Failure to maintain food contact surfaces to protect food from contamination by any source, including unlawful indirect food additives.
Observation #4: The design and materials of equipment and utensils does not allow proper cleaning.
Observation #5: All reasonable precautions are not taken to ensure that production procedures do not contribute contamination from any source.
Observation #6: Employees did not wash and sanitize hands thoroughly in an adequate hand-washing facility at any time their hands may have become soiled or contaminated.
Observation #7: The plaint is not constructed in such a manner as to prevent condensate from contaminating food-contact surfaces.
Observation #8: Non food-contact equipment in manufacturing areas is not constructed so that it can be kept in a clean condition.