- Pressed Juicery, LLC
- Issuing Office:
- San Francisco District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94502-7070
March 23, 2016
Hayden Slater, CEO
3530 E. Church Ave
Fresno, CA 93725
Dear Mr. Hayden Slater:
The U.S. Food and Drug Administration (FDA) inspected your juice manufacturing facility, located at 3530 E. Church Ave, Fresno, CA 93725, on October 13, 14, 21, and 27, 2015, and found that you have serious violations from the FDA's juice Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 120 (21 CFR Part 120). This inspection resulted in FDA’s issuance of a Form FDA-483 Inspectional Observations (FDA-483), at the conclusion of the inspection.
We acknowledge receipt of your response, dated November 11, 2015. Your response included various documents, including a response letter and other supporting documentation. However, our review of the documentation revealed that your response is inadequate, as further described in this letter.
In accordance with 21 CFR Part 120.9, failure of a processor to implement a HACCP plan that complies with the requirements of 21 CFR 120, renders the juice products adulterated within the meaning of the Section 402(a)(4) of the Federal Food, Drug and Cosmetic Act (the Act) [U.S.C. § 342(a)(4)]. Accordingly, your juice products are adulterated in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act, FDA’s juice HACCP regulations, and the Juice HACCP Hazards and Controls Guidance through links in FDA's home page at www.fda.gov1
The violations include, but are not limited to, the following:
1. Your HACCP plan does not include control measures that will consistently produce, at a minimum a 5-log reduction of the most pertinent microorganism(s) of public health significance that is likely to occur in the juice, for at least as long as the shelf life of the product when stored under normal and moderate abuse conditions, as required by 21 CFR 120.24(a). Your HACCP plan for “Ready to Drink Beverages, Soups (Food Drink), Freeze and Toppings,” which includes low acid 100% juices (pH > 4.6), does not have control measures for the pertinent microorganism, Clostridium botulinum. Furthermore, the validation study conducted by Food Microbiological Laboratories to validate the microbial load reduction of Salmonella spp. and E. coli O157:H7 in your juice products using the High Hydrostatic Pressure (HHP) process did not take into consideration the pertinent microorganism C. botulinum for the low acid products. Additionally, FDA recommends you provide a validation study for each of the products you manufacture, to demonstrate, at a minimum, a 5-log reduction of the most pertinent microorganism(s) of concern.
In your November 11, 2015 response to the Form FDA-483, you indicated that you concluded C. botulinum
does not pose a potential risk and is unlikely to occur because C. botulinum
would require temperature abuse and anaerobic conditions. You also stated that there are temperature controls in place throughout processing and during shipping, and that retail labeling indicates “Keep Refrigerated” and a warning statement that the juice product is unpasteurized. FDA finds that your response is inadequate, as the pertinent microorganism means the pathogen that is likely to occur in juice and that is most resistant to the pathogen reduction technology used and if it occurs, is likely to be of public health significance. FDA recommends that firms subject to the pathogen reduction provisions of the juice HACCP regulation who process and produce low acid juices incorporate validated control measures for all C. botulinum
spores into their HACCP plans that will be applied in the processing facility and that will ensure that C. botulinum
growth and toxin production will not occur should the juice, as offered for sale by the processor, be kept unrefrigerated in distribution or by consumers. FDA believes that it is necessary to address the control of hazards that could occur in low acid refrigerated juices subjected to severe temperature abuse. Further guidance on this public health issue can be found at: http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryI…
2. Your HACCP plan must, at a minimum, list all food hazards that are reasonably likely to occur, to comply with 21 CFR 120.8(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.” However, your HACCP plan for “Ready to Drink Beverages, Soups (Food Drink), Freeze and Toppings,” which includes juice blends with apple juice, does not list the food hazard patulin. Because patulin, a mycotoxin, can occur in apple juice from rotting or molding apples and is not destroyed with thermal processing, it is reasonably likely to occur in your juice products that contain apple juice.
We acknowledge your hazard analysis states at the receiving refrigerated goods step “Purchase from approved vendors only. Receipt of supplier guarantee for every shipment (apples harvested to exclude fallen fruit),” and at the sort/trim produce step “Apples are inspected during trimming/culling of apples. Moldy, rotten, and core-rotten apples are discarded as waste.” FDA recommends these steps be included as critical control points with associated critical limits, monitoring, and corrective actions in your HACCP plan.
We may take further action if you do not promptly correct these violations. We may initiate a regulatory action without further formal notice. Such actions may include the initiation of a seizure action against your products and/or an action to enjoin your firm from operating.
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. You may wish to include in your response documentation of corrections your firm has taken or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections within fifteen (15) days, please provide the reason for the delay and provide a timeline for correcting these violations.
This letter may not list all the violations at your facility. You are responsible for ensuring that your firm operates in compliance with the Act, the juice HACCP regulation (21 CFR Part 120), and the Current Good Manufacturing Practice regulation (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
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 a noncompliance materially related to food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection related costs means all expenses, including administrative expense incurred in connection with FDA’s arranging, conducting and evaluating the results of the re-inspection assessing and collecting the re-inspection fees [21 U.S.C § 379j-31(a)(2)(B)]. 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 cost.
Please send your reply to the Food and Drug Administration, Attention:
Lawton W. Lum,
Director of Compliance
1431 Harbor Bay Parkway
Alameda, CA 94502
Please reference Case number 488442
If you have questions regarding this letter, please contact Tammy Hancock at 510-337-6737.
Kathleen M. Lewis, JD