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WARNING LETTER

Apple Tree Goat Dairy MARCS-CMS 509219 —


Recipient:
Apple Tree Goat Dairy


United States

Issuing Office:
Philadelphia District Office

United States


 

  

Black HHS-Blue FDA Logo

 

 

 
PHILADELPHIA DISTRICT
U.S. CUSTOMHOUSE
2ND AND CHESTNUT STREETS
ROOM 900
PHILADELPHIA, PA 19106
TELEPHONE: 215-597-4390

 

WARNING LETTER
17-PHI-04
 
 
VIA UNITED PARCEL SERVICE
OVERNIGHT DELIVERY
RETURN RECEIPT REQUESTED
 
February 10, 2017
 
 
Mrs. Linda H. Nussbaum, Co-Owner
Mr. Lamar N. Nussbaum, Co-Owner
Apple Tree Goat Dairy
129 Nenix Hill Road
Richfield, Pennsylvania 17086-8555
 
Dear Mrs. Nussbaum:
 
The United States Food and Drug Administration (FDA) inspected your ready-to-eat (RTE) unpasteurized and pasteurized goat milk cheese manufacturing facility located at 129 Nenix Hill Road, Richfield, PA 17086, from September 12 to October 11, 2016. During the inspection, FDA collected finished product samples and environmental samples from various areas in your processing facility, including areas that are in close proximity to food and food contact surfaces. FDA laboratory analysis of the environmental samples (i.e., swabs) identified the presence of Listeria monocytogenes (L. monocytogenes), a human pathogen, in your facility, and further FDA laboratory analysis identified the presence of L. monocytogenes in your finished product. Additionally, FDA investigators observed violations of Current Good Manufacturing Practice (cGMP) in Manufacturing, Packing, or Holding Human Food regulation, Title 21, Code of Federal Regulations, Part 110 (21 CFR 110).[1] Based on FDA’s analytical results for the environmental samples and inspectional findings documented during the inspection, we have determined that your RTE cheese products 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. Additionally, based on FDA’s analytical results for the finished product sample that yielded a strain of L. monocytogenes, we have determined that your RTE cheese is contaminated within the meaning of section 402(a)(1) of the Act, 21 U.S.C. § 342(a)(1), in that finished product bears or contains any poisonous or deleterious substance which may render it injurious to health. You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.   
 
This inspection resulted in FDA’s issuance of an FDA Form-483, Inspectional Observations, at the conclusion of the inspection. We acknowledge your firm’s responses received October 24, 2016, and December 7, 2016, which include a description of corrective actions taken by your firm. We address the adequacy of your corrective actions below.
 
Pathogen Findings
 
L. monocytogenes is a pathogenic bacterium that is widespread in the environment and may be introduced into a food processing facility from raw materials, humans, or equipment. Without proper controls, it can proliferate in food processing facilities where it may contaminate food. Therefore, it is essential to identify the areas of the food processing plant where this organism is able to grow and survive and to take corrective actions as necessary to eradicate the organism by rendering these areas unable to support the growth and survival of the organism. Consuming foods contaminated with L. monocytogenes can lead to a severe, sometimes life-threatening illness called listeriosis, a foodborne illness, which is a major public health concern due to the severity of the disease, its high case-fatality rate, its long incubation time, and its tendency to affect individuals with underlying conditions.
 
FDA’s laboratory analysis of fifty environmental swabs collected on September 12, 2016, confirmed that eighteen of the fifty environmental swabs were positive for L. monocytogenes. Additionally, one finished product was positive for L. monocytogenes. Specifically:
 
-    Three positive environmental swabs were collected from the following direct food contact surfaces in your cheese processing room during the production of your RTE cheeses:
  • The top of the cheese slicer
  • The cheese slicer string
  • The inside of a plastic crate used to store finished cheese before packaging
-    The remaining fifteen positive environmental swabs were collected from locations adjacent to food contact surfaces and from non-direct food contact surfaces. 
-    One positive sample was collected from your RTE feta cheese (FDA sample 969273).
 
Whole-Genome Sequencing (WGS) analysis was conducted on the eighteen L. monocytogenes isolates obtained from the FDA environmental samples collected on September 12, 2016, as well as the RTE feta cheese FDA sample 969273. 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 establishes that there are at least two different strains of L. monocytogenes present in the facility. Fifteen of the isolates whose genomes are identical to one another belong to one strain of L. monocytogenes, and the other three isolates whose genomes are identical belong to the second strain of L. monocytogenes. FDA laboratory analysis of vacuum-packaged unpasteurized goat milk RTE feta cheese collected on October 11, 2016, confirmed L. monocytogenes Type 1 in one sub of two analyzed. The WGS analysis for the RTE feta cheese sample showed that the cheese product isolate is nearly identical to the isolates from the environmental samples.
 
The presence of L. monocytogenes in your facility is significant in that it demonstrates your sanitation efforts are inadequate to effectively control pathogens in your facility to prevent contamination of food. It is essential to identify the areas of the food processing plant where this organism is able to grow and survive and to take necessary corrective actions to eradicate the organism by rendering these areas unable to support the growth and survival of the organism.
 
We received your responses on October 24, 2016, and December 7, 2016, outlining the corrective actions you have taken in response to the environmental and product sample findings. We also acknowledge that you agreed on September 22, 2016, to recall all of your cheese products, and that you stated that you are not currently in production.   However, we are unable to evaluate from your response whether you conducted any extensive sampling or testing by a private laboratory to verify that the contamination has been removed from your facility, including food contact surfaces and non-food contact surfaces.  
 
cGMP Violations
 
During the September 12 to October 11, 2016, inspection, 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. For example, our investigators observed the following during the inspection:
 
a)  On September 12, 2016, the lift arm and bowl support brackets of the (b)(4) mixer contained areas which appeared to be rusted and contained rough surfaces. In addition, the beater shaft housing area of the (b)(4) mixer, directly above the bowl support brackets, was observed to contain areas which appeared to be rusted and contain food particulates and/or foreign matter. These areas are in close proximity and/or directly adjacent to food contact surfaces [see 21 CFR 110.40].
 
b)  The floors in the processing room and walk-in cooler were observed to be in disrepair, containing areas where the concrete is cracked, rough, and peeling [see 21 CFR 110.20(b)(4)].
 
We have reviewed your written responses to the Form FDA-483, received October 24, 2016, and December 7, 2016. In your written responses, you indicate the following corrective actions have been taken:
 
a)  A floor mop is now being used to clean the production floor.
b)  (b)(4) is used to clean and sanitize the cheese cloths.
c)  An apparatus has been purchased for storage of production equipment.
d)  The production area hose is hung up and off the floor.
e)  The office area has been cleaned.
f)  The (b)(4) mixer has been cleaned, and the rusted surfaces have been repaired.
g)  The floors of the processing room and walk-in cooler have been repaired.
 
We will ascertain the adequacy of your corrective actions during our next inspection.
 
2.    Your firm failed to take effective measures to exclude pests from the processing areas and protect against the contamination of food on the premises by pests, as required by 21 CFR 110.35(c). Specifically, on September 12, 14, and 22, 2016, our investigator observed:
 
a)  Greater than twenty flies landing on the floor, food processing equipment, food processing utensils, and other food contact surfaces and non-food contact surfaces.
b)  Three fly catcher tapes containing multiple flies hanging in different areas of the processing room.
c)  Dead flies on the window sills near the batch pasteurizer and three bay sink areas. 
 
We have reviewed your written responses to the Form FDA-483, received October 24, 2016, and December 7, 2016. Your written responses state that you installed “new fly catcher tapes . . . and will purchase a fly zapper.” This corrective action is inadequate because it does not prevent insects and/or other pests from entering the facility and does not address why the insects have entered your facility. The regulation at issue requires that pests be prevented from entering any area of a food plant and does not permit that pests be killed in close proximity of food production areas. 
 
3.    Your maintenance of the grounds is inadequate to protect against contamination of food, as required by 21 CFR 110.20(a). Specifically, on September 12 and 14, 2016, our investigator observed: 
 
a) Live chickens and pigs coming within approximately one foot of the main door to the production facility and what appeared to be remnants of dead chickens and goats in close proximity to the production facility.
b) Multiple items within approximately twenty feet of the outside perimeter to your production facility which may constitute an attractant, breeding place, and  harborage areas for pests, including, but not limited to, a chicken coop, an abandoned truck, a small four-wheeled loader, wood paneling, vegetation over six feet tall, and other small items which appear to be refuse.
 
We have reviewed your written responses to the Form FDA-483, received October 24, 2016, and December 7, 2016. Your responses state that you have cleaned the area and added stone along the drive. However, you did not address the livestock and other animals in proximity to the production area and how you plan to maintain those animals. Additionally, you did not confirm that each item observed around the perimeter of your facility was addressed and corrected for FDA review.
 
We will ascertain the adequacy of your corrective actions during our next inspection.
 
(b)(3)(A); (b)(3)(B)
 
This letter is not intended to be an all-inclusive statement of the violations that exist at your firm or in connection with your products. You are responsible for ensuring that your firm is operating in compliance with all the requirements of federal law, including the cGMP regulation [21 CFR Part 110].[2]  
 
You should take prompt action to correct the violations cited in this letter. Failure to do so may result in regulatory action without further notice, including, without limitation, seizure and injunction.
 
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 these violations. You should include in your response documentation such as records, modifications to your cleaning and sanitation standard operating procedures, steps taken to monitor and control contamination in your facility, and other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
 
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 re-inspection-related costs.
 
Please send your reply to the Food and Drug Administration, Attention: Robin M. Rivers, Compliance Officer, 900 U.S. Customhouse, 2nd & Chestnut Street, Philadelphia, PA 19106. If you have questions regarding any issues in this letter, please contact Ms. Rivers at 215-717-3076 or you can email her at robin.rivers@fda.hhs.gov.
 
 
Sincerely,
/S/ 
Anne E. Johnson
District Director
Philadelphia District
 
 
cc:  Mr. Lamar N. Nussbaum, Co-Owner
       Apple Tree Goat Dairy
       129 Nenix Hill Road
       Richfield, Pennsylvania 17086-8555
 
       Pennsylvania State Department of Agriculture
       Bureau of Food Safety and Laboratory Services
       2301 North Cameron Street
       Harrisburg, Pennsylvania 17110-9408
       Attention: Dr. Lydia Johnson, Director
 


[1] 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) (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.