Friday, February 8, 2013

FDA Issues Warning Letter for Inadequate Response To Violations

This article published in the Packer (below) is a cautionary tale on the need for follow-up documentation on ‘actions taken’ in response to violations identified in a regulatory inspection. In summary, after the company had a Listeria contamination recall, they were inspected by FDA. The FDA inspection found Listeria contamination on finished product as well as on food contact surfaces. FDA issued a report to the company. The company responded in a letter about actions that they would take, but did not follow up again that those actions were actually taken and implemented. Because of this, FDA issued a Warning Letter (below) to the company (and we the public get to read about it).

UPDATED: FDA hasn’t closed books on Missa Bay listeria incident
The Packer - 02/06/2013 10:47:10 AM
Coral Beach

UPDATED COVERAGE, Feb. 7) A warning letter from the Food and Drug Administration, made public Feb. 5, indicates the agency is still concerned about listeria contamination found in July at a fresh-cut facility that supplied apple slices to McDonald’s and Burger King restaurants.
The warning letter to Missa Bay LLC — dated Dec. 10 — gave company officials 15 days to respond.

Tamara Ward, FDA press officer, said Feb. 7 the company responded to the December letter but that she could not release details because the investigation is ongoing.

Ward said the FDA sent the letter in December because the company’s officials did not provide followup documentation last fall regarding their listeria control program or their new facility. Ward said the company has since been in communication with the FDA.

Tristan Simpson, marketing director for Missa Bay’s parent company Ready Pac Foods Inc., however, said she has written documentation from the FDA that the case is closed.

The FDA’s December letter references the agency’s investigation from July 27 through Aug. 23 at the Missa Bay facility in Swedesboro, N.J. The agency initiated that action after notification from the U.S. Army Public Health Command that a sample of Missa Bay sliced apples tested positive for listeria.

In August 2012, Ready Pac and
Missa Bay recalled almost 300,000 cases and another 296,000 individual packages of fresh-cut fruit, vegetable and sandwich products because of possible listeria contamination.

The FDA’s December warning letter states that finished product samples plus 27 environmental samples taken at the Missa Bay facility during the 2012 investigation were positive for listeria. Those included samples from food contact surfaces, the non-browning solution used on slices apples, and non-food contact surfaces.

Missa Bay sent a letter to the FDA on Sept. 5 stating it would develop and implement a redesigned listeria control program by Sept. 8, according to the FDA’s Dec. 10 warning letter.

The company’s letter also told the FDA it was moving its apple processing to a “new and redesigned apple processing facility.” FDA’s Ward said the company indicated it was switching from a heat treatment process to a three-stage filtration system.

The 2012 recall included 29 products shipped to retailers and foodservice operations in 36 states and Washington, D.C.
 For more

FDA Inspections, Compliance, Enforcement, and Criminal Investigations
December 10, 2012



Mr. Michael Soloman
President/CEO Missa Bay, LLC
4401 Foxdale Avenue
Irwindale, CA 91706

File No.: 13-NWJ-04

Dear Mr. Soloman:

We inspected your manufacturing facility, located at 2339 Center Square Road, Swedesboro, NJ 08085 from July 27 through August 23, 2012 in response to a report from US Army Public Health Command that a sample of your apple slices yielded Listeria monocytogenes (Lm). During this inspection, finished product, investigational, and environmental samples were collected from your processing facility. A sample of diced and a sample of sliced apples yielded Lm. Consumption of food contaminated with Lm can result in a mild illness (called Listerial gastroenteritis) or a severe, sometimes life-threatening, illness called invasive listeriosis. Immune-compromised individuals and unborn fetuses are particularly susceptible to listeriosis. Accordingly, these apple products are adulterated within the meaning of 402(a)(1) the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(1)] in that they bear or contain a poisonous or deleterious substance which may render them injurious to health.

In addition to the aforementioned finished product samples, Lm was detected on food contact surfaces and non-food contact surfaces in the apple processing room, and in samples of ascorbic acid dip solution. A total of 27 Lm environmental subsamples collected during the inspection yielded Lm. These isolates were indistinguishable as analyzed by PFGE analyses from isolates taken from finished product samples. The presence of PFGE indistinguishable Lm isolates in the environment, food contact surfaces, and finished product samples is indicative of cross contamination as well as harborage problems. Accordingly, products manufactured in your facility are adulterated under 402(a)(4) of the Act [21 U.S.C. § 342(a)(4)], in that, they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. You may find the Act and its associated regulations through links in FDA's home page at

The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist at your facility. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.

Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.

We acknowledge that you have voluntarily recalled all apple products that were produced in your facility between July 8, 2012 and August 20, 2012 and that you have stopped apple product production at the 2339 Center Square Rd. location.

We received your written response, dated September 5, 2012 indicating that you will develop and implement a redesigned Listeria Control and Monitoring Program by September 8, however, you have not provided any further details of this program or supporting documentation to New Jersey District as evidence of its implementation.

The response also states that you have abandoned the (b)(4) in favor of a (b)(4), including (b)(4), for the new and redesigned apple processing facility; however, you did not provide documentation of the efficacy of the new process in controlling Lm.

Furthermore, you identify the source of the Lm contamination as the "(b)(4)," but you do not mention any corrective actions taken to correct the (b)(4) that you identified as "not designed or constructed in a manner that would allow for adequate dismantling, cleaning and inspection." During the inspection it was noted that you were moving certain pieces of apple processing equipment to your new processing facility. A firm representative stated that the equipment would be tagged and environmentally sampled prior to being moved to the new facility to ensure that no Lm remained. The results of this sampling were not provided with your response.

FDA recommends that you identify all areas of your facility where Lm is able to grow and survive (niche areas) and take such necessary corrective action as necessary to control the organism. Please be advised that FDA has issued draft guidance entitled "Guidance for Industry: Control of Listeria monocytogenes in Refrigerated or Frozen Ready-To-Eat Foods; Draft Guidance". You may submit comments on this draft guidance to the agency as outlined in the document. The draft guidance is available online at:

Your response should be addressed to U.S. Food and Drug Administration, 10 Waterview Boulevard, 3rd Floor, Parsippany, New Jersey, 07054, Attn: Kerry Kurdilla, Compliance Officer.



Diana Amador-Toro
District Director
New Jersey District

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