Inspections, Compliance, Enforcement, and Criminal Investigations
Persimmon Hill Farm Gourmet Foods 8/31/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Kansas City District
August 31, 2012
RETURN RECEIPT REQUESTED
Ref. KAN 2012-15
Earnest Bohner, Owner
Persimmon Hill Farm Gourmet Foods
367 Persimmon Hill Lane
Lampe, Missouri 65681-7380
Dear Mr. Bohner:
On May 3 through May 17, 2012, the U.S. Food and Drug Administration (FDA) conducted an investigation of your facility located at 367 Persimmon Hill Lane, Lampe, Missouri. The inspection revealed that you manufacture acidified foods, juice products, and other food products at this facility.
We found that you have serious deviations from the Acidified Food regulations described in Title 21, Code of Federal Regulations (CFR) Part 108, Emergency Permit Control (21 CFR Part 108) and Part 114, Acidified Foods (21 CFR Part 114 ). As a manufacturer of acidified food products, you are required to comply with the Federal Food, Drug, and Cosmetic Act (the Act), and the federal regulations relating to the processing of acidified food products. The Emergency Permit Control regulation was issued, in part, pursuant to Section 404 of the Act [21 U.S.C. § 344]. A temporary emergency permit may be required for acidified food products whenever a processor has failed to fulfill the requirements of 21 CFR Part 108, Subpart B, including registration and filing of process information, and the mandatory requirements of 21 CFR Part 114. In addition, based on certain criteria in Part 114, acidified foods may be adulterated within the meaning of Section 402(a)(3) of the Act [21 U.S.C. § 342(a)(3)] in that they consist in whole or in part of any filthy, putrid, or decomposed substance, or within the meaning of Section 402(a)(4) [21 U.S.C. § 342(a)(4)] in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. For your reference, the Act and the Emergency Permit Control and Acidified Food regulations can be located on the Internet through links on the FDA's homepage at http://www.fda.gov.
We also found that you may have serious deviations from the Juice Hazard Analysis and Critical Control Point(HACCP) regulation described in Title 21, Code of Federal Regulations, Part 120, Hazard Analysis and Critical Control Point (HACCP) Systems (21 CFR Part 120). As a manufacturer of juice products, you would be required to comply with the Act, and federal regulations relating to the processing of juice products. In accordance with 21 CFR 120.9, failure of a processor to have and implement a HACCP plan that complies with the requirements of Part 120, renders the juice products adulterated within the meaning of Section 402(a)(4) of the Act [21 U.S.C. § 342(a)(4)]. Accordingly, your shelf-stable bottled juice products may be adulterated in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. We have provided comment relative to HACCP requirements for your firm's "Elderberry Juice".
Our office is in receipt as of June 13, 2012 of your undated letter addressing the initial steps you are taking to correct the deviations noted on the Form FDA 483, Inspectional Observations, issued at the close of the inspection on May 17, 2012. We have reviewed this response and find the corrective actions, in general, to be inadequate, as the response appears to be isolated to the specifics of only the observations on the FDA 483 and does not satisfactorily address many of the deviations. This response does not address the underlying causes of the other violations which may include ineffective oversight of personnel and record review. To date, your response does not provide assurance to our office that you have taken effective measures necessary to prevent recurrence of the deviations.
During the inspection, our investigators documented violations of the Act and deviations from the above-mentioned acidified food regulations relating to the processing of the acidified food "Shiitake Mushroom Sauce". These deviations cause your acidified food products to be adulterated and in violation of Section 402(a)(4) of the Act [21 U.S.C. § 342 (a)(4)], in that your acidified foods have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. These deviations were documented on Form FDA 483, Inspectional Observations, which was issued to you on May 17, 2012.
The significant deviations from 21 CFR Part 114 which the investigators observed at your acidified food manufacturing facility are as follows:
• Your firm failed to fully reprocess, thermally reprocess as a low-acid food under 21 CFR 113, or set aside for further evaluation as to any potential public health significance, a portion of food which deviated from a scheduled process, as required by 21 CFR 114.89. Specifically, "Shiitake Mushroom Sauce" with lot code "(b)(4)" was held for sale in your warehouse and was not quarantined or placed on-hold for evaluation by your process authority, even though a process deviation occurred during the production of this lot where the minimum time and requirements were not The scheduled process for this product (SID (b)(4)) lists fill temperature at (b)(4) F with (b)(4) minute hold. Your firm's processing record for this product lot shows only (b)(4) F after (b)(4) minutes hold. This data represents a processing deviation for an acidified food that your firm failed to deal with in accordance with the requirements of 21 CFR 114.89.
Your FDA 483 response documents that you' have modified your batch production record for the "Shiitake Mushroom Sauce" to include a "Release signature", so that no product will be placed into the warehouse without your "Release signature". This requirement of a release signature still does not ensure that you will identify and record process deviations, as you failed to identify process deviations on previous batch production records, even though you were involved in filling out the batch production records.
• Your firm failed to note, identify, and record departures from a scheduled process having a possible bearing on public health or the safety of a food, as required by 21 CFR 114.100(c). Specifically,
a. You failed to identify a process deviation, or record the deviation, for "Shiitake Mushroom Sauce" with lot code "(b)(4)", in that Lot (b)(4) was processed at (b)(4) degrees F. However, the scheduled process for this product (SID (b)(4)) lists fill temperature at (b)(4) F with (b)(4) minute hold.
b. You failed to identify a process deviation, or record the deviation, for "Shiitake Mushroom Sauce" with lot code "(b)(4)", in that Lot (b)(4) was actually processed at approximately (b)(4) degrees F for (b)(4) minutes. However, the scheduled process for this product (SID (b)(4)) lists fill temperature at (b)(4) F with (b)(4) minute hold. Although the batch production record notes the process temperature and time as (b)(4) degrees (b)(4) F for (b)(4) minutes, the mis-calibration of the thermometer to read (b)(4) degrees F at the boiling point of water instead of the approximately (b)(4) degrees F at the approximate elevation of (b)(4) feet of your facility resulted in Lot (b)(4) actually being processed at approximately(b)(4) degrees F for (b)(4) minutes instead of (b)(4) degrees F for (b)(4) minutes.
Your FDA 483 response asserts you will correctly calibrate your thermometer in the future. However, this does not address the failure to identify and record the obvious process deviation associated with Lot (b)(4) of "Shiitake Mushroom Sauce".
• Your firm failed to employ appropriate quality control measures to ensure that finished goods do not present a health hazard, as required by 21 CFR 114.80(a). Specifically, 21 CFR 114.80(a) requires that acidified foods shall be so manufactured, processed and packaged that a finished equilibrium pH value of 4.6 or lower is achieved within the time designated in the scheduled process and maintained in all finished foods. If the finished equilibrium pH of the food is above 4.0, the measurement of the finished equilibrium pH shall be by a potentiometric method. The schedule process for Shitake Mushroom Sauce (SID (b)(4)), calls for a fill temperature of (b)(4) F with a maximum finished equilibrium pH of (b)(4)
a. You failed to record the results of calibration activities for both the pH meter controls/adjustments and the thermometer adjustments used to measure the critical factors of pH and temperature for "Shiitake Mushroom Sauce" with lot code "(b)(4)"
b. You failed to record the results of calibration activities for the pH meter controls/adjustments used to measure the critical factor of pH for "Shiitake Mushroom Sauce" with lot code "(b)(4)". Additionally, your batch record for this Lot (b)(4) documents that the thermometer was calibrated in boiling water and the thermometer was adjusted to read (b)(4) degrees F in boiling water instead of the approximately (b)(4) degrees F for the boiling point of water at the elevation of your facility.
Your FDA 483 response asserts you have modified your batch production record to record pH meter calibration activities. This observation is a repeat observation from the last inspection in August 2010, and after the last inspection you committed to recording pH meter calibration activities but failed to do so.
The deviations identified above are not intended to be an all-inclusive list of deficiencies at your facility. Other violations can subject your food to legal action. It is your responsibility to ensure that your facility is in compliance with all requirements of the Act, the Emergency Permit Control regulations (21 CFR Part 108), the Acidified Food regulations (21 CFR Part 114), and the Juice HACCP regulation (21 CFR Part 120). It is also your responsibility to assure that all of your products are in compliance with applicable statutes and regulations enforced by FDA.
You should take prompt measures to correct all of the deviations noted in this letter. Failure to promptly correct these deviations may result in regulatory action without further notice, such as seizure, injunction, and/or issuance of an Order of Need to obtain and hold a Temporary Emergency Permit.
You should notify this office in writing, within 15 working days of receipt of this letter, of any additional steps you have taken to correct the noted deviations and to prevent their recurrence. 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. Please include copies of any available documentation demonstrating that corrections have been made.
We cannot determine based on the information provided whether your firm's 100% Elderberry Juice is indeed 100% elderberry juice, subject to the juice HACCP regulation. We note from the batch logs for 100% Elderberry Juice and from your firm's statements, that water is added to the product by the firm to make up for water that is lost due to evaporation. In order to determine whether the product is 100% juice and subject to the juice HACCP regulation, the degrees brix of the final product would have to be known. If the 100% elderberry juice product is determined to be single strength juice and, therefore, subject to the juice HACCP regulations, your firm would have juice HACCP deviations. Accordingly, we present the comments below concerning compliance with the juice HACCP regulations. We do note that your firm's thermal process is much more robust than is necessary to address any potential pathogen concerns.
We would expect that your firm's process to produce a shelf stable juice. would meet the criteria for exemption from the 5 log pathogen reduction requirement in 21 CFR 120.24(a)(2). However, we did not see any documentation to show that the process authority assessed the process to determine if the process would achieve shelf stability in all cases where your firm intentionally adds water to the product. The process authority in his letter of May 15, 2012 reviewed only the process for specific batches due to the mis-calibration of the thermometer. Your firm should obtain is a letter from your process authority stating that your regular addition of water to juice will result in a shelf stable product even in the case of maximal addition. If such is the case, your firm would be exempt from the requirement to have control measures for achieving a 5-log reduction.
If the product is determined to be 100% elderberry juice, subject to the juice HACCP regulation, your firm should:
• Demonstrate that its standard practice of adding water to batches of elderberry juice will under all circumstances, still result in a product that is shelf stable and thus exempt from the 5-log pathogen reduction requirement under 21 CFR 120.24(a)(2).
• Include the pH adjustment/monitoring step as a Critical Control Point (CCP) in the firm's HACCP plan unless the process authority can stipulate that pH control is not necessary for the process to render the product shelf stable.
• Establish Sanitation Standard Operating Procedures (SSOPs)that comply with 21 CFR 120.6.
o There is documentation in the Establishment Inspection Report (EIR) that your firm handles soy products on the equipment used for processing elderberry juice. We a agree with your firm's determination with respect to their "Processing in "(b)(4)" step in their hazard analysis (Appendix G of firm's response to FDA 483) that proper cleaning of equipment between batches will eliminate the potential allergen hazard due to cross contact. However, such cleaning should be carried out through an SSOP regime (SSOPs, monitoring of conditions and practices to ensure compliance with Part 110, and record keeping) which is not documented in the EIR and appears to be lacking in your firm's HACCP operations.
• Address in your hazard analysis whether glass fragments are a potential hazard. There is documentation in the EIR that glass bottles are used to package some of your product, yet there is no documentation in your firm's hazard analysis that your firm considered the potential for glass fragments to be a hazard.
• After the above issues have been addressed, your firm's revised HACCP plan would be subject to the validation requirement of 21 CFR 120.11.
Please direct your reply to Amy E. Devine, Compliance Officer, at the address listed above. If you have any questions regarding any issue in this letter, please contact Ms. Devine at the above address or at phone number (913) 752-2719.
John W. Thorsky
Kansas City District