In an Oct. 26 warning letter to company president Aaron Hollander, the FDA cited “significant deviations” at the Alle Processing Corp. facility in Maspeth, NY. The company produces shelf-stable and frozen low-acid foods.
Inspectors documented ‘a temperature inaccuracy during re-calibration of one Mercury In Glass thermometer that resulted in the potential under-processing of all LACF (low-acid canned foods) products manufactured by (the) firm between approximately Feb. 1, 2016 through Feb. 19, 2017.
The thermometer was showing temperatures that were off by 4 degrees F compared to the required minimum public health sterilizing requirements, which can result in dangerous bacterial growth and other foodborne pathogens.
Inspectors also found the company’s thermometers were overdue for calibration, which can result in inaccurate readings as were observed during the FDA inspection.
It should also be noted that this is a repeat observation from the previous FDA inspection, conducted on Aug. 12, 2015, where we found a MIG thermometer installed on Retort #5 that was overdue for calibration. The tag on the unit indicated that it was last calibrated on ‘1/30/2014’ and that it was due for calibration on “1/30/15,” ‘ according to the warning letter.
Another problem pending since 2015 involves Alle Processing Corp. failing to meet federal law that requires food manufacturing companies to report new processes to the FDA. Specifically, the company implemented a new process schedule, developed in August 2015, for the manufacture of shelf-stable gefilte fish in jelled broth without telling the FDA about the changes. Inspectors cited concerns about heat penetration during the fish production process.