Aspen Hills, Inc. 1/10/17
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Kansas City District Office
8050 Marshall Drive - Suite 205
Lenexa, Kansas 66214-1524
January 10, 2017
VIA UPS OVERNIGHT DELIVERY
RETURN RECEIPT REQUESTED
Thomas S. Lundeen, President & Co-Owner
Nancy J. Lundeen, Secretary Treasurer & Co-Owner
Aspen Hills, Inc.
830 N. State St. Garner, IA 50438
Reference CMS Case# 509769
Dear Mr. and Mrs. Lundeen:
The U.S. Food & Drug Administration (FDA or we) inspected your frozen cookie dough (including ready-to-eat (RTE) cookie dough) manufacturing facility located at 830 N. State St., Garner, IA 50438, from September 27 through October 6, 2016. During our inspection, FDA collected environmental samples from various areas in your processing facility. FDA laboratory analyses of the environmental swabs found the presence of Listeria monocytogenes (L. monocytogenes), a human pathogen, in your facility. Additionally, FDA investigators observed serious violations of the Current Good Manufacturing Practice (CGMP) regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110).1
Based on FDA’s analytical results for the environmental samples and inspectional findings documented during the inspection, we determined that your frozen cookie dough (including RTE cookie dough) products commonly called pucks, pellets, and pails are 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), 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 and FDA's regulations through links in FDA's home page at http://www.fda.gov.
This inspection resulted in FDA’s issuance of an FDA Form-483, Inspectional Observations (FDA-483), at the conclusion of the inspection. We acknowledge your firm’s responses dated November 1, 2016, and December 19, 2016, to the FDA-483, which include a description of corrective actions taken by your firm. We address the adequacy of specific corrective actions below.
Presence of L. monocytogenes
L. monocytogenesis a pathogenic bacterium that is widespread in the environment. It can proliferate in food processing facilities without proper controls, where it may contaminate food. Consuming these contaminated foods can lead to a severe, sometimes life-threatening illness called listeriosis, a foodborne illness that is of major public health concern because of the severity of the disease, its high case-fatality rate, long incubation time, and tendency to affect individuals with underlying conditions or who are otherwise more susceptible to illness.
FDA laboratory analysis of the environmental samples collected on September 28, 2016, confirmed that four environmental swabs were positive for L. monocytogenes. The four positive environmental swabs were collected from the manufacturing area in the following locations:
- On the second stair/rung of the ladder well leading to the elevated control room. This ladder is adjacent to the (b)(4) used on the cookie dough (b)(4).
- On the wheels of the pallet jack used to move food products within the production room. The pallet jack was located in the (b)(4) of the production room adjacent to the (b)(4) at the time of sampling.
- On the basket located in the (b)(4), which is adjacent to the (b)(4) where the exposed cookie dough receives (b)(4).
- In the (b)(4), which is adjacent to the (b)(4) where the exposed cookie dough receives (b)(4).
Between September 18 and 26, 2016, your firm’s environmental program detected L. monocytogenes in ten environmental swabs and in one finished product lot of cookie dough product, which was not distributed into commerce. The frequency of these environmental findings in conjunction with your finished product finding indicates that your firm is not taking aggressive action to identify harborage sites for L. monocytogenes, to deep clean your facility effectively, and to prevent finished product contamination.
Whole Genome Sequencing (WGS) analysis was conducted on the four previously mentioned L. monocytogenes isolates obtained from the FDA environmental samples collected on September 28 and the eleven previously mentioned L. monocytogenes isolates detected by your firm’s environmental program (including one finished product sample). WGS analysis of bacterial human pathogens provides high-resolution data, enabling direct links to be established between clinical isolates and food or environmental sources of bacterial contamination and illness. WGS data can also be used to infer the evolutionary relationships (or phylogeny) within a given set of isolates as it measures each DNA position in a bacterial genome. The WGS phylogenetic analysis of these 15 isolates finds that they comprise a single strain of L. monocytogenes. Comparing this strain to the larger WGS database shows that it matches three other isolates: two isolates from finished ice cream products tested by a commercial laboratory, and one isolate from a cookie dough ingredient sample collected by the state of Texas in 2016.
The presence of L. monocytogenes in your facility is significant because it demonstrates your cleaning and sanitation practices are inadequate to effectively control pathogens in your facility to prevent contamination of food. Furthermore, L. monocytogenes found in the environment of your facility increases the risk of your finished product becoming contaminated. Once established in a production area, personnel or equipment can facilitate the pathogen’s movement and contamination of food-contact surfaces and finished product. It is essential to identify the harborage sites in the food processing plant and equipment where this organism is able to grow and survive and to take such corrective actions as necessary to eradicate the organism by rendering these areas unable to support the growth and survival of the organism.
We acknowledge after our findings, your firm took extensive corrective actions. This included hiring a third-party laboratory and consultant group to conduct a comprehensive review of your operations and to make recommendations for changes in your policy and procedures. It also included revising your Standard Operating Procedures ("SOPs") in three critical areas: (1) environmental pathogen monitoring; (2) product sampling and testing; and (3) cleaning and sanitizing facilities. We will ascertain the adequacy of your corrective actions during our next inspection. Additionally FDA acknowledges your firm conducted a voluntary recall to include all lots of RTE cookie dough produced at your facility between June 8 and September 30, 2016, as a result of the Agency’s inspectional findings, the detection of L. monocytogenes within your processing environment, and the results of the WGS analysis.
FDA investigators observed the following significant violations of the CGMP regulation for foods [21 CFR Part 110]:
1. Your firm failed to take all reasonable precautions to ensure that production procedures do not contribute contamination from any source, as required by 21 CFR 110.80. Examples of the lack of such precautions include the following:
a. On September 27, 2016, employees were observed conducting their (b)(4) cleaning process, which included spraying the floors using (b)(4) spray nozzles connected to hoses, while there were (b)(4) buggies containing uncovered, in-process White Chocolate Macadamia cookie dough on the production floor [see 21 CFR 110.80(b)(5)]. Standing water was observed on the floor surrounding the exposed products in the buggies [see 21 CFR 110.37(b)(4)].
Your firm’s response indicates that you improved management oversight and provided additional training to ensure product is not exposed during the cleaning process. It also indicates that (b)(4) cleaning with water will not begin until after all products are in the process of being packaged and removed from the production floor, except that cleaning with water may begin on the opposite end of the production room from the packaging machines, approximately (b)(4). We will ascertain the adequacy of your corrective action during our next inspection.
b. Residual flour, shortening, and liquid pasteurized egg ingredient were observed on the floor of your production room. Your employees, pallet jack, and forklift were observed entering and exiting the production room, passing through the product build-up on the floor and leaving defined imprint trails.
Your firm’s response indicated that you have addressed appropriate cleaning of spills through retraining employees and ensuring stronger management over existing procedures. Your response also indicates that you have changed procedures to eliminate traffic through the production room. We will ascertain the adequacy of your corrective action during our next inspection.
c. Employees were observed to be moving in and out of the production room to take trash to a dumpster, located in an adjacent room, wearing rubber boots and aprons also used during production. An employee’s apron brushed against the dumpster while throwing away the trash, and other employees were observed picking up empty raw material bags lying on the production room floor, carrying them against their aprons to the dumpster outside the production room to dispose of the empty bags in the dumpster. Each time the employees were observed re-entering the production room, they were wearing the same rubber boots and aprons without cleaning or sanitizing them.
Your firm’s response indicates that you have changed procedures to limit employee movement from the production room to the warehouse, amended your procedures with respect to the use of overshoes in the production room, (b)(4) by the entrance to the production room, and improved training and management oversight. We will ascertain the adequacy of your corrective action during our next inspection.
d. On September 27, 2016, during the cleaning process, an employee was observed spraying the floor and drain of the production room. Overspray from the floor was observed splashing on the equipment parts, such as augers used to process cookie dough.
Your firm’s response indicates that you have revised your cleaning procedures and taken steps to train employees in the proper techniques for cleaning and sanitizing equipment to ensure it is ready for production. Your response also indicates you (b)(4) to create an open area to prepare for cleaning without risking splatter to other areas of the production room. We will ascertain the adequacy of your corrective action during our next inspection.
2. Your firm failed to ensure that cleaning and sanitizing of utensils and equipment is conducted in a manner that protects against contamination of food, food-contact surfaces, or food-packaging materials, as required by 21 CFR 110.35(a). Specifically, our investigators observed:
a. On September 27, 2016, employees were observed dispensing pasteurized liquid egg product from a tote into metal pails for the purpose of weighing them on a scale. The scale was observed to be covered in pasteurized liquid egg product throughout the production day.
Your firm’s response indicates you are retraining employees and enforcing an existing policy to clean up spills as they occur. In addition, your response indicates that you plan to introduce disposable gloves and train employees on the proper use and replacement of gloves. Your response indicates the training will be ongoing. We will ascertain the adequacy of your corrective action during our next inspection.
3. Your firm failed to maintain equipment so as to facilitate cleaning of the equipment, as required by 21 CFR 110.40(a). Specifically our investigators observed:
a. Apparent rust on the (b)(4) used to cut cookie dough as it leaves the (b)(4) on the (b)(4)
b. Apparent rust and degradation of the bottom edges of the (b)(4)
mixers in the production room used to mix all products manufactured by your firm.
c. Missing bolts from the upper white plastic edge of the (b)(4) mixer. The missing bolt holes were observed to contain debris while mixing White Chocolate Macadamia puck dough.
Your firm’s response indicates that you have adopted a new SOP which requires the replacement of the (b)(4) and that requires a (b)(4). Your response indicates that you plan to (b)(4) for a more cleanable surface. Your response indicates that you have cleaned and replaced the missing bolts. We will ascertain the adequacy of your corrective action during our next inspection.
FDA acknowledges that your firm conducted a voluntary recall and considers the 19 RTE cookie dough products, all manufactured between June 8, 2016, and September 30, 2016, that your firm recalled beginning on September 20, 2016, and expanded on October 9, 2016, and on November 9, 2016, to have posed an acute, life-threatening hazard to health.
The FDA has designated your recall as Class I. This classification is based on findings of L. monocytogenes in your products and in the production environment. Information regarding your recall will be published in the weekly FDA Enforcement Report. FDA’s policy regarding recalls is published in 21 CFR Part 7. Our Kansas City District Office Recall Coordinator will remain in contact with you until this matter is resolved.
This letter is not intended to be an all-inclusive list of the violations that exist in connection with your products. It is your responsibility to ensure that your products are in compliance with the Act and all applicable laws, including the Current Good Manufacturing Practice regulation for foods [21 CFR Part 110].2
You should take prompt action to correct these violations cited in this letter. Failure to do so may result in regulatory action without further notice, including without limitation, seizure and injunction.
Additionally, FDA has the following comments on your corrective action documentation:
1. Your firm’s response indicates that you continue to maintain a (b)(4) procedure for you RTE products. However, you did not include details of this (b)(4) procedure such as the amount of product manufactured and (b)(4), the results of the analyses of the product, and the disposition of any affected lots of product.
2. Your firm’s response referenced procedures that did not appear to contain a version number or an implementation date. Therefore, it is difficult to know when some of the procedures were implemented and may be difficult for your employees to know if the procedure is current. For example, your response indicates you were enforcing and retraining employees on existing procedures; however, the training records supplied with your response show employees were trained on topics such as “Sanitation” (9/13/16) and “Highlighted Proper Sanitation, High APC counts and Importance of properly cleaned facility” (9/15/16). These trainings were just prior to the start of our inspection on September 27, 2016, and therefore cannot be considered to constitute corrective actions to issues identified during the inspection. It is your responsibility to ensure that training is effective and understood by your employees.
You should respond in writing within fifteen working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct violations, including an explanation of how your firm plans to prevent the recurrence of the violations described above or the occurrence of similar violations. More specifically, your response should include documentation of the corrections and/or corrective actions (which should address systemic problems) your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Please include copies of any available documentation demonstrating corrections have been made.
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 reinspection-related costs. A reinspection 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. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees [21 U.S.C. 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for reinspection-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 reinspection-related costs.
Your response should be sent to Andrew A. Hoopes, Compliance Officer, U.S. Food and Drug Administration, 210 Walnut Street, Suite 369, Des Moines, IA 50309. If you have any questions about this letter, please contact Compliance Officer, Andrew A. Hoopes at 515-244-0480, ext. 1002 or firstname.lastname@example.org.
Cheryl A. Bigham
Kansas City District Office
Part 110 was modernized and codified in Subpart B of Part 117 by the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (21 CFR Part 117) (CGMP & PC rule). An establishment will continue to be subject to Part 110 until the Part 117 compliance date applicable to its business size. See http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm334115.htm#Compliance_Dates for PC rule compliance dates.
2 See footnote 1 for further information about the recent modernization of Part 110 and the possible applicability of Part 117.