January 23, 2018

FDA Warning Letters for September 2014

The FDA has sent a warning letter to M & B Sea Products of New Bedford, Massachusetts, alleging that the facility has “serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation.” The company’s refrigerated, reduced oxygen packaged raw, scallops are adulterated.

FDAThe facility does not have an HACCP plan to list critical limits to be met. Because the scallops were not refrigerated at a temperature below 38Ā°F, Clostridium botulinum toxin can form. FDA inspectors found fresh dry scallops packed in metal cans stored in the walk-in cooler, which meant they could not be visually examined. The firm did not maintain monitoring records for two days in July 2014. In addition, the company did not have anyone trained in seafood HACCP to perform necessary functions.

A warning letter was sent to Ipsi Specialty Foods in Nebraska. That facility produces pickled chicken eggs. The firm was not registered with the FDA as a commercial processor of acidified foods, in spite of processing those foods for up to 35 years. There is no acidified food scheduled process filed with the FDA. Eggs are a low acid food, and it is critical that processing methods be approved to prevent the growth of botulism toxin.

The facility was deficient, since there was rust and peeling paint on the ceiling in the raw egg storage room, rust on the ceiling in the egg cooking room, and loose ceiling tiles in the egg cooking room. Employees were observed not washing their hands. Hair nets were not worn, and there was not adequate lighting in several areas.

Japanese Specialty Food Distributors in Connecticut was warned about violations of seafood HACCP regulations. A hazard analysis plan was not conducted for each kind of fish. The facility was not monitoring the safety of water that comes into contact with food. In addition, there was no prevention of cross-contamination from insanitary objects, maintenanceĀ of hand washing, proper labeling and use of toxic chemicals, and exclusion of pests.

Finally Modern Macaroni Co. of Hawaii was warned about violations of seafood HACCP regulations. The company’s shrimp flakes and noodles were adulterated. There was no HACCP plan to control for allergens. The level of cleaning in the facility was not adequate to prevent microbial growth and cross-contamination. Trays were constructed of worn wood material that is not easily cleaned. There were also problems with mislabeling and misbranding.

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