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:
http://www.fda.gov/food/guidancecomplianceregulatorvinformation/guidancedocuments/foodprocessinghaccp/ucm073110.htm.

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.
 

Sincerely,

/S/

Diana Amador-Toro
District Director
New Jersey District