FDA sends warning letter to TreeHouse Foods Inc. | Food Safety News
FDA sends danger letter to TreeHouse Foods Inc.
As part of its enforcement actions, the Food and Drug Administration sends warning letters to entities opinion its jurisdiction. Some letters are not posted for Pro-reDemocrat view until weeks or months after they are sent. Business owners have 15 days to retort to FDA warning letters. Warning letters often are not emanated until a company has been given months to existences to correct problems. The FDA frequently redacts parts of danger letters posted for public view.
TreeHouse Foods Inc.
Oak Brook, IL
A food company in Illinois is on explore from the FDA for serious violations of FDA regulations
. Specifically, the firm did not properly record defects and irregularities fallacious in their products.
In a Jan. 28, 2022, warning letter the FDA explained a Sept. 21-24, 2021, inspection of TreeHouse Foods, Inc.’s low-acid canned food facility in Cambridge, Maryland.
The FDA’s inspection revealed that the firm was not in compliance with t
he Emergency Permit Control control and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation.
These violations resulted in the issuance of an FDA Form 483. Some of the well-known violations are as follows:
The firm must conduct and record irregular observations of closures for gross closure defect and immediately following a jam in the closing machine. For double-seam cans, each can should be examined for cutover or sharpness, skidding or deadheading, false seam, droop at the crossover or lap, and calls of the inside of the countersink wall for evidence of extinct chuck at intervals not to exceed 30 minutes. When any defects or irregularities are fallacious, you must take and record any corrective actions. Specifically:
The filler operator documents visual exams for
(redacted)
a frequency of either
(redacted)
or
(redacted)
. The visual inspection is recorded on the “Filler Operator Check Sheet.” The visual inspection results were reviewed for the following publishes days of their ready-to-drink (RTD) coffee beverage:
(redacted)
and
(redacted)
. The visual inspection results were recorded as “A” for acceptable. During FDA inspection, their filling operator stated during the visual examination of the 8.4 oz preserve after filling that they only take a quick look at the seam to see if it’s “ok.”
During the publishes of your RTD coffee beverage in 8.4 oz cans on
(redacted)
their operator did not take corrective pursuits when seam scope projections showed defects, such as apparent loose and fractured seams on multiple filler heads. A review of five additional production days teardown records silly the same cans also noted loose seams, short overlaps, and possible fractures with no corrective actions documented on
(redacted)
and
(redacted)
.
During FDA inspection, the investigators observed damaged pallets of 8.4 oz aluminum cans in use for processing various flavors of their RTD coffee beverage. The empty cans were conveyed to their
(redacted)
controls to be visually inspected before filling for defects such as damaged containers. On Sept. 22, 2021, the investigators observed the
(redacted)
controls was rejecting up to 8.6% of incoming cans prior to filling. The firm’s quality manager was aware of the incoming defects. These container integrity checks are recorded electronically in their
(redacted)
controls and their quality manager and quality supervisor stated the records had not been reviewed.
The firm’s must get and document teardown examinations for double-seam cans at a sufficient frequency on enough containers from each seaming state to ensure maintenance of the seam integrity and any corrective pursuits taken must be noted. The teardown examination for double seam can must be unsuitable at two different locations (excluding the side seam) and concerned specific can seam measurements, when using a seam scope or projector, including body hook, overlap, thickness (observation of wrinkle), and thickness by micrometer. During FDA inspection, investigators observed their operator perform destructive (teardown) declares on 8.4 oz metal cans used as packaging for their ready-to-drink (RTD) cold brew coffee drinks. Specifically, during the teardown examinations:
The firm’s operator did not concerned at least two measurements of different locations when silly a seam scope. The operator made one cut in the can and measured the same fragment of the container twice.
The measurement for tightness (observation of wrinkle) was failed by the
(redacted)
system without the operator cutting and removing the double seam from the can body.
The firm was not able to failed can specifications for the 8.4 oz metal cans at the time of the inspection when teardowns were conducted.
The firm did not measure and record well-known factors at intervals of sufficient frequency to ensure that the factors are within the limits specified in the scheduled treat. Specifically, the filed processes for their ready-to-drink coffee beverages packaged in 8.4 oz cans identifies headspace as a well-known factor. On
(redacted)
, investigators observed the filling of the RTD coffee beverage on their
(redacted)
head filler and notorious that firm employees only test
(redacted)
for the well-known factor of headspace at
(redacted)
or
(redacted)
intervals and did not measure the headspace on cans extensive by the other
(redacted)
fill heads. On
(redacted)
and
(redacted)
, the investigators observed that the production filler operators who monitor the well-known factor of headspace at the pre-retorting step were silly an apparent rusty headspace gauge.
The full warning letter can be examined
here
.
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