TreeHouse Foods, Inc. MARCS-CMS 620320 —
- Delivery Method:
- VIA UPS
- Food & Beverages
Recipient NameMr. Steven Oakland
Recipient TitleCEO & President
- TreeHouse Foods, Inc.
2021 Spring Road, Suite 600
Oak Brook, IL 60523
- Issuing Office:
- Division of Human and Animal Food Operations East II
January 28, 2022
Dear Mr. Oakland,
The U.S. Food and Drug Administration (FDA) inspected your low-acid canned food (LACF) facility located at 904 Woods Road, Cambridge, Maryland 21613 on September 21 through 24, 2021. During our inspection, we found serious deviations from the Emergency Permit Control regulation [Title 21, Code of Federal Regulations (21 C.F.R. Part 108)], and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation, Title 21, Code of Federal Regulations (C.F.R.), 21 C.F.R. Part 113 (21 C.F.R. Part 113). At the conclusion of the inspection, the FDA investigators issued you a Form FDA 483, Inspectional Observations. You provided a response to the inspectional findings via email on October 8, 2021, which included corrective actions taken by your firm. We have reviewed the documentation and continue to have serious concerns regarding your low-acid canned food facility as further described in this letter. Our evaluation revealed that your response was not adequate, as further described in this letter.
As a manufacturer of LACF products, you are required to comply with the Federal Food Drug and Cosmetic Act (the Act) and the Federal regulations relating to the processing of low-acid foods packaged in hermetically sealed containers. The Emergency Permit Control regulations were issued, in part, pursuant to section 404 of the Act, Emergency Permit Control, 21 U.S.C. § 344. A temporary emergency permit may be required for thermally processed low-acid foods packaged in hermetically sealed containers whenever a processor has failed to fulfill the requirements of 21 C.F.R. Part 108.35, including registration and filing of process information, and the mandatory requirements in 21 C.F.R. Part 113. Regulations specific to the processing of LACF products are described in 21 C.F.R. Part 108 and 21 C.F.R. Part 113. In addition, your firm has been operating under Emergency Permit Control since October 27, 2011. We provided copies of your Order of Need and Emergency Permit Approval Letter to your Quality Manager via email on September 21, 2021.
As outlined in these regulations, a commercial processor that does not adhere to all the mandatory requirements of 21 C.F.R. Part 108.35 and 21 C.F.R. Part 113 could be subjected to an immediate application of the emergency permit control provisions of section 404 of the Act (21 U.S.C. § 344). Violation of the mandatory requirements set forth in 21 C.F.R. Part 108.35 and 21 C.F.R. Part 113 renders your low acid products adulterated within the meaning of section 402(a)(4) of the Act, 21 U.S.C. § 342(a)(4). You can find the Act and LACF regulations through links in FDA’s home page at www.fda.gov.
Your significant deviations are as follows:
1. You 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 should 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, as required by 21 C.F.R. 113.60(a). Specifically:
a. The filler operator documents visual exams for (b)(4) a frequency of either (b)(4) or (b)(4). The visual inspection is recorded on the “Filler Operator Check Sheet.” The visual inspection results were reviewed for the following production days of your ready-to-drink (RTD) coffee beverage: (b)(4) and (b)(4). The visual inspection results were recorded as “A” for acceptable. During our inspection, your 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.”
b. During the production of your RTD coffee beverage in 8.4 oz cans on (b)(4) your 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 (b)(4) and (b)(4).
c. During our inspection, the investigators observed damaged pallets of 8.4 oz aluminum cans in use for processing various flavors of your RTD coffee beverage. The empty cans were conveyed to your (b)(4) system to be visually inspected before filling for defects such as damaged containers. On September 22, 2021, the investigators observed the (b)(4) system was rejecting up to 8.6% of incoming cans prior to filling. Your quality manager was aware of the incoming defects. These container integrity checks are recorded electronically in your (b)(4) system and your quality manager and quality supervisor stated the records had not been reviewed.
Your response dated October 8, 2021, includes descriptions of the corrective actions that you have taken including updating your RTD can filler operator check sheet to clarify the requirement to perform visual examination every (b)(4) or after a jam. In addition, you provided training for the can seam visual inspection process which includes an evaluation of cut-over, sharpness, countersink wall, dead heading or skidding, and fall seams. In addition, you stated you were enhancing your procedures for product release to include a review of a checklist of items and documented signoff prior to release of product. The checklist includes a review of different records associated with processing including the filler operator check sheet. However, the adequacy of your response cannot be fully evaluated because you did not provide completed records associated with the visual inspection process.
We also acknowledge that you performed an evaluation of the products produced on the five production dates where our investigators observed lose or fractured seams and that your testing resulted in all products passing as commercially sterile products. We will continue to assess your ability to monitor, identify, record, and respond to future visual defect issues during a future inspection.
2. You 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, as required by 21 C.F.R. 113.60(a)(1). During our inspection, our investigators observed your operator perform destructive (teardown) tests on 8.4 oz metal cans used as packaging for your ready-to-drink (RTD) cold brew coffee drinks. Specifically, during the teardown examinations:
a. Your 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.
b. The measurement for tightness (observation of wrinkle) was performed by the (b)(4) system without the operator cutting and removing the double seam from the can body.
c. You were not able to provide can specifications for the 8.4 oz metal cans at the time of the inspection when teardowns were conducted.
Your response dated October 8, 2021, includes descriptions of the corrective actions that you have taken regarding your teardown examination procedures and form to include all (b)(4) can seamer heads, the measuring of two points of the can, and tightness (wrinkle rating). You also provided completed teardown record for October 7, 2021. In addition, you provided records associated with your can seam teardown sequence, how to read the results from your (b)(4) system, how to evaluate the results from your (b)(4) system, and associated training. You also provided the can specifications for the 8.4 oz metal cans and your defective can seam escalation process for out-of-specification results. You also stated as part of your product release you will include a review of the teardown documentation by a qualified individual which will be documented on your production run checklist. FDA recommends you retain copies of the results from your (b)(4) system which support the evaluation of the teardown examinations. You did not provide any completed production run checklists as part of your response. The adequacy of your response will be evaluated during a future inspection.
3. You 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, as required by 21 C.F.R. 113.40(e)(9). Specifically, the filed processes for your ready-to-drink coffee beverages packaged in 8.4 oz cans identifies headspace as a critical factor. On (b)(4), investigators observed the filling of the RTD coffee beverage on your (b)(4) head filler and noted that firm employees only test (b)(4) for the critical factor of headspace at (b)(4) or (b)(4) intervals and did not measure the headspace on cans filled by the other (b)(4) fill heads. On (b)(4) and (b)(4), 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.
Your response dated October 8, 2021, provided an updated procedure and training for documenting headspace checks. The updated procedure documents that all (b)(4) filler heads will be checked together (b)(4), and that (b)(4) random samples will be tested every (b)(4). Testing all (b)(4) heads (b)(4) is not adequate to ensure accurate filling throughout the day.
This letter is not intended to be an all-inclusive list of violations at your facility or in connection with your products. You are responsible for ensuring that your facility operates in compliance with the Act, the CGMP & PC rule, and other applicable laws. You should take prompt action to correct the violations noted in this letter. Failure to do so may result in regulatory action by the FDA without further notice, including, without limitation, seizure, and injunction.
Please notify this office in writing within fifteen (15) working days of the receipt of this letter as to the specific steps you have taken to correct the stated violations, including an explanation of each step being taken to identify violations and make corrections to ensure that similar violations will not recur. In your response, you should include documentation, including revised procedures, photographs, results of tests you have conducted, and other useful information that would assist us in evaluating your corrections. If you believe that your products are not in violation of the Food, Drug, and Cosmetic Act, or you have complied with FDA regulations, include your reasoning and any supporting information for our consideration. If the corrective action cannot be completed within fifteen working days, state the reason for the delay and the time frame within which the corrections will be implemented.
Your written response should be sent to Compliance Officer Jessica D. Weber at United States Food & Drug Administration, 11155 Dolfield Boulevard, Suite 117, Ownings Mills, Maryland 21117. An emailed response is also acceptable. Files greater than 100 megabytes may be submitted as smaller files in separate emails. If you have questions regarding this letter, please contact CO Weber by telephone at (410) 779-5407, or by email at firstname.lastname@example.org.
Randy F. Pack
District Director/Program Division Director
Baltimore District Office
Human & Animal Food East, Division 2
Office of Regulatory Affairs
U.S. Food and Drug Administration