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  5. Osage Lane Creamery LTD - 12/03/2015
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Osage Lane Creamery LTD

Osage Lane Creamery LTD

United States

Issuing Office:
Cincinnati District Office

United States


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

Public Health Service
Food and Drug Administration
 Cincinnati District Office
Central Region
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-2775


December 3, 2015
Ms. Emma J. Stout, President
Osage Lane Creamery, LTD
5168 Refugee Rd., SW
Pataskala, Ohio 43062
Warning Letter
Dear Ms. Stout:
The United States Food and Drug Administration (FDA) conducted an inspection of your raw goat milk Feta cheese manufacturing facility, Osage Lane Creamery, LTD, located at 5168 Refugee Rd. SW, Pataskala, Ohio on May 21, 22 and June 16, 2015. During our inspection, FDA investigators collected an environmental sample consisting of multiple swabs taken from various areas within your processing facility. FDA laboratory analyses of the environmental swabs found the presence of a human pathogen Listeria monocytogenes (L. monocytogenes) 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].  Based on FDA’s analytical results for the environmental sample and inspectional findings documented during the inspection, we determined that your food 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 were prepared, packed or held under insanitary conditions whereby they may have been rendered injurious to health. You can find the Act and FDA’s regulations through links on FDA’s home page at http://www.fda.gov.
This inspection resulted in FDA’s issuance of a Form FDA-483, Inspectional Observations (FDA-483), at the conclusion of the inspection. We acknowledge your firm’s July 8, 2015, response to the FDA-483, which includes a description of corrections to the observations of concern noted on the FDA-483. However, your response does not provide comprehensive information to ensure the adequacy of your corrective actions in addressing the violations observed during the inspection. After review of the inspectional findings and your firm’s response, your firm’s significant deviations remain as follows:   
FDA laboratory analysis of the environmental sample collected from various locations within your firm’s processing facility on May 21, 2015, confirmed that one (1) of the seventy three (73) environmental swabs was positive for L. monocytogenes. The positive swab was collected from Northeast corner of your processing room floor, approximately two feet from the kettle used to heat ingredients to manufacture cheese.  Furthermore, this was not the first time FDA investigators collected environmental samples from your facility that were found to be positive for L. monocytogenes.  During our July 16-19, 2012 inspection, FDA laboratory analysis of the environmental sample collected on July 17, 2012, confirmed two (2) environmental swabs was positive for L. monocytogenes.  The reoccurring 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. 
Appropriate control of L. monocytogenes in a food processing environment requires expert knowledge of the unique characteristics of the organism. It is essential to identify the areas of the food processing plant 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.
L. monocytogenes is 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, an atypical foodborne illness of major public health concern due to the severity of the disease, its high case-fatality rate, long incubation, and predilection for individuals with underlying conditions.
FDA investigators also observed the following significant violations of the Current Good Manufacturing Practice regulation for foods [21 CFR Part 110]:
  1. Your firm failed to ensureall reasonable precautions shall be taken to ensure that production procedures do not contribute contamination from any source, as required by 21 CFR Part 110.80.  Specifically,
    1. An employee was observed carrying milk cans from the onsite goat barn to your facilities processing room and placing the milk cans directly on the floor.  Goat milk from these cans was observed being hoisted, poured into a kettle, and placed directly back on to the floor.  A water hose was then observed being used to spray and rinse the cans when they were on the processing floor. The water hose nuzzle used to spray and rinse these cans was observed touching the inside of the milk cans, this same hose was later used to spray the inside of the manufacturing kettle.
    1. A number of insanitary conditions were observed in your processing facility, including, standing water on the floor; dead insects and spiders on the walls and processing floor; and dirt and debris build-up on plastic storage buckets sitting directly on the floor in the processing room used in cheese processing to catch whey from in-process cheese draining from plastic molds.
2. Your firm failed to ensure work-in-progress is handled in a manner that protects against contamination, as required by 21 CFR Part 110.80(b)(5). While you were manufacturing feta cheese, excessive humidity was observed in the processing room which caused condensate to form on the corrugated ceiling in various locations, including directly above exposed in-process feta cheese. At the close-out of the inspection, you stated you have an air conditioner to help mitigate the amount of moisture build-up during your processing.  In addition you state in your response that you did not see any moisture. However, during the inspection, our investigators took photographs documenting the presence of the condensation in your firm during cheese manufacturing.
The above violations are not meant to be an all-inclusive list of violations that may exist at your facility or with respect to your products. It is your responsibility to assure that your facility and your products are in compliance with the Act and all applicable regulations. You should take prompt action to correct all of the violations noted in this letter and to implement procedures to prevent such violations from recurring. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction.

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 respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct these violations. Please also include documentation or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, please explain the reason for your delay and state when you will correct any remaining violations.
Your written response should be sent to Allison C. Hunter, Compliance Officer, U.S. Food and Drug Administration, 6751 Steger Drive, Cincinnati, Ohio 45237. If you have any questions about this letter, please contact Compliance Officer Hunter at 513-679-2700 Ext. 2134.
Steven B. Barber
District Director
Cincinnati District