Breaking news for everyone's consumption
As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems. The FDA frequently redacts parts of warning letters posted for public view.
Ebenezer International Food LLC South Burlington, VT
An import company in Vermont is on notice from the FDA for not having FSVPs for a number of imported food products.
In an Aug. 30 warning letter, the FDA described a May 5, 2021, Foreign Supplier Verification Program (FSVP) inspection of Ebenezer International Food LLC in South Burlington, VT.
The FDA’s inspection revealed that the firm was not in compliance with FSVP regulations and resulted in the issuance of an FDA Form 483a.
The firm did not develop, maintain, and follow an FSVP for any of the foods they import, including the following foods:
The FSVP requires importers to verify that their foreign suppliers of food for human and animal consumption meet applicable FDA safety standards.
The full warning letter can be viewed here .
Banner Smoked Fish Inc. Brooklyn, NY
A food firm in New York is on notice from the FDA for serious violations of Seafood Hazard Analysis and Critical Control Point (HACCP) regulation. At least one person has been sickened by product(s) from the facility.
In a Nov. 8 warning letter, the FDA described inspections on May 5,10, 12, 21, 24 and 26, and June 7-9 and 21, 2021, of Banner Smoked Fish Inc.’s ready-to-eat (RTE) cold- and hot-smoked seafood processing facility in Brooklyn, NY.
The FDA’s inspection revealed that the firm was not in compliance with FDA regulations and resulted in the issuance of an FDA Form 483.
Presence of Listeria monocytogenes FDA laboratory analysis of the environmental sample 1154266 collected on May 5, 2021, from various areas in the firm’s processing facility, including food-contact surfaces and areas adjacent to food-contact surfaces, confirmed that seven out of 101 environmental swabs collected were positive for Listeria monocytogenes . Of the positive findings, two swabs were collected from the following food-contact surfaces: a wax paper lining on a metal tray that was holding RTE cold-smoked salmon prior to packaging and the surface of a spoon that was used to clean belly portions of whole salmon intended to be cold smoked. Additionally, five swabs were found positive for Listeria monocytogenes on areas directly adjacent to food-contact surfaces including a scale used to weigh trays of RTE cold-smoked salmon.
Whole genome sequencing (WGS) was conducted on seven Listeria monocytogenes isolates obtained from the FDA environmental sample collected on May 5, 2021, and two Listeria monocytogenes isolates obtained from the FDA environmental sample collected on Dec. 3, 2019. The current WGS analysis determined that the isolates derived from the samples collected at the facility, referenced above, represent six different strains of Listeria monocytogenes . One of these strains, from the environmental sample collected from their facility on May 5, 2021, is a genomic match to a clinical isolate collected from an ill person, which indicates that this strain has the capability of causing human illness.
iii. Brushes in the slicing room were noted to be visibly dirty with apparent cold-smoked salmon particles in the bristles. These brushes were later used to conduct cleaning operations of equipment located in the slicing room, including a stainless steel packing table.
Additional comments: The firm’s revised HACCP plan included a Flow Diagram that states “ (redacted)” is used. Any substance added to food needs to be authorized by a food additive regulation, effective food contact notification (FCN), or be generally recognized as safe (GRAS) for the intended use. There is no FDA regulation nor effective FCN allowing use of peracetic acid (also known as peroxyacetic acid, directly on seafood. There are FCNs for use of PAA mixtures as a (redacted) agent in wash water and/or ice used in preparation of seafood. Please note that FCNs are only effective for the notifier and their manufacturer/supplier. For example, if the firm is purchasing their food contact substance from a manufacturer or supplier who has their own effective FCN for that use, use of their formulation would be authorized. We recommend that the firm provide additional information on how PAA is being used in their operations, including the legal basis for its use.
The full warning letter can be viewed here .
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