Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/apple-tree-goat-dairy-509219-02102017
Timestamp: 2020-07-05 11:35:49
Document Index: 106231296

Matched Legal Cases: ['art 110', '§ 342', '§ 342', 'art 110', 'art 110', 'art 117']

Apple Tree Goat Dairy - 509219 - 02/10/2017 | FDA
Apple Tree Goat Dairy - 509219 - 02/10/2017
Apple Tree Goat Dairy MARCS-CMS 509219 — February 10, 2017
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.
- 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).
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.
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:
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:
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.
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.
[2] See footnote 1 for further information about the recent modernization of Part 110 and the possible applicability of Part 117.