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WARNING LETTER

Seedling Enterprise, LLC 19/05/2016

Seedling Enterprise, LLC - 05/19/2016


Recipient:
Seedling Enterprise, LLC


United States

Issuing Office:
Detroit District Office

United States


  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 Detroit District
300 River Place
Suite 5900
Detroit, Ml 48207
Telephone: 313-393-81 00
FAX: 313-393-8139

 

WARNING LETTER
2016-DET-11
 
 
May 19, 2016
 
VIA UPS
 
Mr. Peter I. Klein, Owner and Managing Member
Seedling Enterprises, LLC
6717 111th Street
South Haven, MI  49090
 
Dear Mr. Klein:
 
The U.S. Food and Drug Administration (FDA) received your firm’s response on December 9, 2015, to the issued FDA FDA-483, which issued after an inspection at your juice manufacturing facility located at 6717 111th Street, South Haven, Michigan, on October 8 through 22, 2015. This inspection revealed serious violations of the juice Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 120, (21 CFR 120). In accordance with 21 CFR Part 120.9, failure of a processor to have and implement a HACCP plan that complies with the requirements of 21 CFR 120, renders the juice products adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)]. Accordingly, your 100% All Natural Apple Cider, 100% Golden Delicious Apple Cider, 100% Mutsu Apple Cider, Tart Cherry Apple Cider, Cinnamon Spice Apple Cider, and 100% Pear Cider are adulterated in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.
 
You may find the Act, FDA’s juice HACCP regulations, and the Juice HACCP Hazards and Controls Guidance through links in FDA's home page at www.fda.gov.
 
After review of the inspectional findings and your firm’s response, your firm’s significant deviations remain as follows:
 
1.     You must include in your hazard analysis and HACCP plan control measures that will consistently produce, at a minimum, a 5-log reduction of the pertinent microorganism for at least as long as the shelf life of the product when stored under normal and moderate abuse conditions, to comply with 21 CFR 120.24(a). The "pertinent microorganism" is defined as "the most resistant microorganism of public health significance that is likely to occur in the juice,” 21 CFR 120.24(a). Your juice process includes ultraviolet (UV) light treatment of all juices as your 5-log pathogen reduction step. However, your firm has not validated, as required by 21 CFR 120.11(b), that the ultraviolet light treatment achieves a minimum 5-log reduction of the most pertinent organism for your Tart Cherry Apple Cider, Cinnamon Spice Apple Cider, and 100% Pear Cider juice products.
 
2.     Your HACCP plan must, at a minimum, list the critical limits that must be met at each critical control point, to comply with 21 CFR 120.8(b)(3). A critical limit is defined in 21 CFR 120.3(e) as “the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food hazard.”  Your HACCP plan for cider, dated August 1, 2015, lists critical limits that do not prevent, eliminate, or reduce to an acceptable level an identified food hazard, as follows:
 
a.     Your HACCP plan’s critical limit to control the hazard of patulin at the Product Receiving critical control point (CCP) states, “(b)(4)”  FDA recommends that your critical limit include that each shipment of incoming fruit is accompanied by a supplier guarantee specifying that only apples harvested to exclude fallen fruit were supplied in the shipment.
 
b.     Your HACCP plan’s critical limit to control the hazard of patulin at the Inspection (b)(4) CCP, where it appears your firm is culling product, states, “(b)(4)”  FDA recommends that your critical limit include the use of only apples or apple portions free of mold, rot, bruising, and other damage. Additionally, FDA recommends that your critical limit further explain the quantified parameters to include no more than 1% by weight rot after culling.
 
c.     Your HACCP plan’s critical limit at the UV Pasteurization CCP to control pathogens, including E. coli O157:H7 and Cryptosporidium parvum, states, “Equipment passes 5 log reduction test.”  FDA recommends that your critical limit include all critical factors as established by your process authority, including, but not limited to, a requirement that all juice passes through the ultraviolet light system. Additionally, according to the HACCP guidelines supplied by the UV system manufacturer, your critical limit should include a requirement that the system’s UV sensor tamper tags are intact.
 
d.     Your HACCP plan’s critical limit at the Filters CCP to control the physical hazard of foreign objects states, “(b)(4)”  FDA recommends that your critical limit at this CCP includes that the filter is intact and fully functional, without tears or holes.
 
3.     Your HACCP plan must, at a minimum, list the procedures, and frequency with which they are to be performed, that will be used to monitor each of the critical control points to ensure compliance with the critical limits, to comply with 21 CFR 120.8(b)(4).  However, your HACCP plan for cider, dated August 1, 2015,  lists monitoring procedures and frequencies which are not adequate to control the hazards, as follows:
 
a.     Your HACCP plan’s Product Receiving CCP for control of the hazard of patulin lists a monitoring procedure and frequency that states, “(b)(4)”  FDA recommends your monitoring procedure includes specifications for what you are monitoring, how you will perform this monitoring, the frequency at which this monitoring will occur, and who will perform this task. Specifically, for this CCP, FDA recommends that your firm is monitoring that a supplier guarantee exists for each incoming shipment of apples, by a visual confirmation of the supplier guarantee, at a frequency of each fruit shipment.
 
b.     Your HACCP plan’s Inspection (b)(4) CCP for control of the hazard of patulin lists a monitoring procedure and frequency that states, “(b)(4)”  Your identified monitoring procedure is not adequate because it does not specifically quantify the parameters of your critical limits. FDA recommends your monitoring procedure includes specifications for what you are monitoring, how you will perform this monitoring, the frequency at which this monitoring will occur, and who will perform this task. Specifically, for this CCP, FDA recommends that your firm is monitoring how much rot is present in a quantified weight sample, by a visual inspection and weight of damaged pulp, at an identified frequency during your production run.
 
c.     Your HACCP plan’s UV Pasteurization CCP for control of the hazard of pathogens, including E. coli O157:H7 and Cryptosporidium parvum, lists a monitoring procedure and frequency that states, “(b)(4).”  Your identified monitoring procedure is not adequate because it does not specifically identify parameters to ensure comprehensive monitoring of your critical limits. FDA recommends your monitoring procedure includes specifications for what you are monitoring, how you will perform this monitoring, the frequency at which this monitoring will occur, and who will perform this task. Specifically, for this CCP, FDA recommends that your firm is continuously monitoring critical parameters including the UV sensors, UV lamps, and pump flow rate, of your UV processing unit with a visual check at an identified frequency during your processing.
 
d.     Your HACCP plan’s Filters CCP for control of the hazard of foreign objects lists a monitoring procedure and frequency that states, “(b)(4).”  Your identified monitoring procedure is not adequate because it does not specifically identify the parameters to insure comprehensive monitoring of your critical limits. FDA recommends your monitoring procedure includes specifications for what you are monitoring, how you will perform this monitoring, the frequency at which this monitoring will occur, and who will perform this task. Specifically, for this CCP, FDA recommends that your firm monitors if the screen of your filter is intact, by a visual inspection at an identified frequency during your processing.
 
4.    You have included pre-determined corrective actions in your HACCP plan for cider, dated August 1, 2015. Accordingly your described corrective actions must be appropriate to comply with 21 CFR 120.8(b)(5) to ensure affected product is not entered into commerce and the cause of the deviation was corrected. Specifically:
 
a.    Your HACCP plan’s Product Receiving CCP lists corrective actions of, “(b)(4).”  This corrective action is not adequate because it does not address the cause of the deviation. In addition to (b)(4), FDA also recommends discontinuing the supplier until an agreement is in place and fulfilled. FDA also recommends that each shipment of fruit be accompanied by a supplier guarantee.
 
b.    Your HACCP plan’s UV Pasteurization CCP lists corrective actions of, “(b)(4)”  This corrective action is not adequate because it does not address how your firm will handle product that could potentially be under-processed, and it does not address the cause of the deviation. FDA recommends segregating and holding product for reprocessing and identifying and fixing the cause of this mechanical failure.
 
c.    Your HACCP plan’s Filters CCP lists corrective actions of, “rework if object found.”  This corrective action is not adequate because it does not address the cause of the deviation. In addition to reworking the product, FDA also recommends addressing the filter malfunction by replacing the filter screen to ensure the cause of the deviation is addressed.
 
5.    Your HACCP plan for cider, dated August 1, 2015,  does not list the verification procedures that have been developed to ensure that the HACCP plan is being implemented to comply with 21 CFR 120.8(b)(6), as follows:
 
a.    According to the UV system manufacturer’s HACCP guidelines, the system’s UV sensors should be calibrated (b)(4) whichever comes first. However, your HACCP plan does not include calibration of the UV sensors. Further, your firm has not calibrated the sensors since they were replaced approximately three years ago.
 
b.    According to a May 2015 letter from your UV system supplier, the UV tubes should be revalidated (b)(4). However, your verification procedures and frequency listed in your HACCP plan at your UV Pasteurization CCP are, “(b)(4).”
 
6.    You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure conformance with good manufacturing practice regulations, to comply with 21 CFR 120.6(b).  However, your firm did not monitor the safety of water that comes into contact with food or food contact surfaces, including water used to manufacture ice, condition and cleanliness of food contact surfaces, and exclusion of pests, as indicated by the following:
 
a.    Two spiders were observed inside the pasteurized cider holding tank, which an employee said had been cleaned and sanitized earlier that day.
 
b.    Numerous flying insects were observed in the processing area, which had an open door to the storage area, which, in turn, had an open exterior door.
 
c.    No backflow prevention devices were observed at the following connections to your potable water system:
 
i.     On hose connections to water lines at the well head, on a spigot at the northeast corner of the building, and on a hose in the processing room.
 
ii.     On the water connection to the (b)(4).
 
We may take further action if you do not promptly correct these violations. For instance, we may initiate a regulatory action without further formal notice. Such actions may include the initiation of a seizure action against your products and/or an action to enjoin your firm from operating. 
 
Please respond in writing within fifteen (15) business days from your receipt of this letter. Your response should outline the specific actions you have taken to correct these deviations. Include in your response documentation of the corrections your firm has taken, or other useful information that may assist us in evaluating your corrections. If you cannot complete all corrective actions within 15 days, please provide the reason for the delay and provide a timeline for correcting remaining violations.
 
This letter may not list all the violations at your facility. You are responsible for ensuring that you firm operates in compliance with the Act, the juice HACCP regulation (21 CFR 120), and other applicable regulations. You also have a responsibility to use procedures to prevent further violations of the Federal Food, Drug, and Cosmetic Act and all applicable regulations.
 
Additionally, we have the following comments regarding your HACCP plan:
 
Your HACCP plan lists the general term, “bacteria,” as the pertinent microorganism at your UV Pasteurization CCP. The “pertinent microorganism” is the most resistant microorganism of public health significance that is likely to occur in the juice and is the pathogen that must be targeted for the 5-log pathogen reduction treatment (21 CFR 120.24(a)). FDA recommends that you consider identifying which bacterial pathogens are pertinent microorganisms of concern. Specifically, E. coli O157:H7, a bacterial pathogen, and Cryptosporidium parvum, a protozoan parasite,have been the cause of outbreaks in untreated apple juice and we would recommend identifying these bacterial pathogens to be the pertinent microorganisms of concern that are reasonably likely to occur in your apple and apple blend juices.
 
Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees (21 U.S.C. 379j-31(a)(2)(B)). For a domestic facility, FDA will assess and collect fees for re-inspection related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection related costs.
 
Please send your reply to the Food and Drug Administration, Detroit District Office, Attention: Seri Essary, Compliance Officer, at the above letterhead address. 

If you have questions regarding any issue in this letter, please contact Ms. Essary at (313)393-8150.
 
Sincerely,
/S/ 
Art O. Czabaniuk
District Director
Detroit District Office