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  5. Burnham Orchards, Inc. - 03/23/2016
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Burnham Orchards, Inc.

Burnham Orchards, Inc.

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


March 23, 2016
Warning Letter
Via United Parcel Service
Mr. Joseph T. Burnham, IV CEO/Owner
Burnham Orchards, Inc.
8019 State Route 113 East
Berlin Heights, OH 44814
Dear Mr. Burnham:
On November 10, 13, 25 and 27, 2015, the U.S. Food and Drug Administration (FDA) conducted an inspection of your apple cider processing facility located at 8019 State Rt. 113 East, Berlin Heights, OH. The inspection revealed serious violations of the juice Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations (CFR), Part 120 and the Current Good Manufacturing Practice (CGMP) regulation for foods. (21 CFR Parts 120). 
Accordingly we have determined that your apple cider is 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 it may have become contaminated with filth, or whereby it may have been rendered injurious to health. You can find this Act and the corresponding regulations through links on FDA’s homepage at www.fda.gov
During our inspection, we observed the following significant violations:
1.    Your HACCP plan must list the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 120.8(a) and (b)(1). A food hazard is defined in 21 CFR 120.3(g) as “any biological, chemical or physical agent that is reasonably likely to cause illness or injury in the absence of its control.”  You combined an incomplete hazard analysis, process flow and HACCP plan in a table format.  One of your tables does not include the food safety hazards that are related to your juice product, such as Escherichia coli 0157:H7, Cryptosporidium parvum, patulin and metals.  A similar table, dated 9/14/2014, does not include patulin as a food hazard. It is unclear which table and/or HACCP plan you are currently using.
2.    You must have a HACCP plan that lists the procedure(s) and frequency(ies) 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 firm’s HACCP plan for apple cider lists a procedure/frequency of “Inspection Temperature Chart recorder” that is not adequate to ensure compliance with the identified critical limit of “Temperature Remains Above (b)(4) Actual running Temp is between (b)(4)”. Specifically, your monitoring procedure/frequency at the “Equipment Temperature” critical control point to control pathogens in your apple cider indicates you will monitor the temperature chart recorder.  However, your critical limit also includes a time aspect, i.e. (b)(4); therefore, you should also be monitoring the flow rate of apple cider through the pasteurization process.  You should also include the monitoring frequency in your HACCP plan.  FDA recommends that you monitor time and temperature continuously during pasteurization.
3.    You are not maintaining the SSOP records that, at a minimum, document the monitoring and corrections to comply with 21 CFR 120.6(c). Your firm did not monitor the safety of water, exclusion of pests, the protection of food and prevention of cross contamination, as evidenced by:
a.    Live fruit fly like insects too numerous to count flying above and landing on power cord above the uncovered grinder hopper containing apple pomace and at least five fruit like insects hovering around the uncovered openings of two apple cider tanks.  Additionally, dead fruit fly like insects too numerous to count on the tops and lids of the two processed cider holding tanks.
b.    Failure to provide a backflow prevention device on your three wash hoses in the production room.
c.    Failure to provide a hand washing sink in the processing room.
d.    A buildup of a brown colored residue has grown on the wooden handled tool used to move apples from the dump bin to the culling area.
e.    Clean nylon press cloths used during manufacturing are stored on rusty cart handles.
f.    Employee health conditions are not being monitored or documented.
g.    The employee and public restroom are not being monitored or documented for cleanliness and supplies.
h.    Failure to measure and document chlorine based sanitizer concentrations.
i.    A rodent bait trap was stored between the pasteurizer and the processed juice storage tank in the production room.
4.    Since you chose to use corrective actions in your HACCP plan, your described corrective action must be appropriate, to comply with 21 CFR 120.8(b)(5). However, your corrective action procedures do not address identifying and correcting the cause of the deviation as required by 21 CFR 120.10(a). Specifically, your corrective/preventative action does not adequately address deviations from the Metal Detection (food safety hazard of metals) as CCPs for your HACCP plan for apple cider. Your corrective actions in your plan do not address the state of the product, the cause or correction of the deviation.
5.    You must have and implement a sanitation standard operating procedure that addresses sanitation conditions and practices before, during and after processing, as required by 21 CFR 120.6(a). However your firm’s written sanitation standard operating procedure does not include the exclusion of insects from the cider processing room.
The above-identified deviations are not intended to be an all-inclusive list of deficiencies at your food manufacturing facility. It is your responsibility to ensure that your firm is in compliance with all requirements of the Act and federal regulations. You should take prompt action to correct the current deviations. Your failure to promptly correct these deviations may result in administrative and/or regulatory action without further notice. 
Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to asses and collect fees to cover FDA’s costs for certain activities, including re-inspection–related costs. A re-inspection is one or more inspection conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance had 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)].
Please notify this office in writing within 15 working days of receipt of this letter of the specific steps you have taken or will take to correct the noted violations and to prevent their recurrence. Include documentation of any corrective action you have taken. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed. 
Your response should be sent to: Food and Drug Administration, Attention: Allison C. Hunter, Compliance Officer, 6751 Steger Drive, Cincinnati, OH 45237-3097. If you have questions regarding any issues cited in this letter, please contact Ms. Hunterat 513-679-2700, Extension 2134 or at allison.hunter@fda.hhs.gov.
Steven B. Barber
District Director
Cincinnati District
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