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.
TreeHouse Foods Inc.
Oak Brook, IL
A food company in Illinois is on notice from the FDA for serious violations of FDA regulations. Specifically, the firm did not properly record defects and irregularities found in their products.
In a Jan. 28, 2022, warning letter the FDA described 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 the Emergency Permit Control regulation 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 significant violations are as follows:
- The firm must conduct and record regular observations of closures for gross closure defect and immediately following a jam in the closing machine. For double-seam cans, each can be examined for cutover or sharpness, skidding or deadheading, false seam, droop at the crossover or lap, and condition of the inside of the countersink wall for evidence of broken chuck at intervals not to exceed 30 minutes. When any defects or irregularities are found, 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 production 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 container after filling that they only take a quick look at the seam to see if it’s “ok.”
- During the production of your RTD coffee beverage in 8.4 oz cans on (redacted) their operator did not take corrective actions 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 using 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) system to be visually inspected before filling for defects such as damaged containers. On Sept. 22, 2021, the investigators observed the (redacted) system 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) system and their quality manager and quality supervisor stated the records had not been reviewed.
- The firm’s must perform and document teardown examinations for double-seam cans at a sufficient frequency on enough containers from each seaming station to ensure maintenance of the seam integrity and any corrective actions taken must be noted. The teardown examination for double seam can must be taken at two different locations (excluding the side seam) and include 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) tests 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 include at least two measurements of different locations when using a seam scope. The operator made one cut in the can and measured the same section of the container twice.
- The measurement for tightness (observation of wrinkle) was performed by the (redacted) system without the operator cutting and removing the double seam from the can body.
- The firm was not able to provide 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 critical factors at intervals of sufficient frequency to ensure that the factors are within the limits specified in the scheduled process. Specifically, the filed processes for their ready-to-drink coffee beverages packaged in 8.4 oz cans identify headspace as a critical factor. On (redacted)investigators observed the filling of the RTD coffee beverage on their (redacted) head filler and noted that firm employees only test (redacted) for the critical factor of headspace at (redacted) or (redacted) intervals and did not measure the headspace on cans filled by the other (redacted) fill heads. On (redacted) and (redacted)the investigators observed that the production filler operators who monitor the critical factor of headspace at the pre-retorting step were using an apparent rusty headspace gauge.
The full warning letter can be viewed here.
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