- Delivery Method:
- VIA UNITED PARCEL SERVICE
- Reference #:
- Food & Beverages
Recipient NameMr. Angel J. Sanchez
- Jugos La Torre
Road 4131, Km. 2.0, Bo. La Torre
- Issuing Office:
- Division of Human and Animal Food East IV
September 12, 2017
17-HAFE4-WL-10 / CMS No. 537085
Dear Mr. Sanchez:
We inspected your juice processing facility located in Lares, PR on May 18, 2017 through June 06, 2017 (dates not all inclusive) and found that you have serious deviations from the FDA's juice processing regulations. In accordance with Juice HACCP regulations under Title 21 CFR, Part 120, juice processed and packed by your firm at your facility is rendered 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 contaminated with filth or may have been rendered injurious to health. You may find the Act, the juice HACCP regulation, and the Juice HACCP Hazards and Controls Guidance through links in the FDA’s home page at http://www.fda.gov.
Significant violations observed during the inspection are as follows:
1. You do not have a written HACCP plan as required in accordance with 21 CFR Part 120.8(a).
2. You do not have a written Hazard Analysis in accordance with 21 CFR Part 120.7(a) to determine whether there are food hazards that are reasonably likely to occur for each type of juice you produce. We acknowledge a Hazard Analysis was provided during the close-out of the inspection and it will need to be evaluated during a follow up inspection. Please ensure your written Hazard Analysis identifies any hazards as reasonably likely to occur, it must have a HACCP plan to address those hazards.
3. You do not have controls in place for the pathogens, nor do you perform a 5-log reduction for juice you process in accordance with 21 CFR Part 120.24 and as evidenced by the following:
- You do not monitor or have records of supplier’s guarantees.
- You do not have a (b)(4) step.
- You do not have a pasteurizer or other means to achieve a 5-log reduction at your processing facility.
4. You are not monitoring the sanitation conditions and practices in accordance with 21 CFR 120.6(b) with sufficient frequency to assure conformance with Current Good Manufacturing Practice (CGMP). Specifically, your firm does not monitor any of the key eight sanitation elements.
Your firm’s response dated June 16, 2017, indicates that some observations were corrected and you also requested a 30-day extension to complete all corrections to the observations that have not been corrected. We have reviewed your firm’s written response and it is inadequate. You failed to specify the observations which were corrected including submitting documents to show full implementation of corrective and preventive actions. Also, specific timeframes to implement corrections to all observations were not established.
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 mean all expenses, including administrative expenses, incurred in connection with FDA's arranging, conducting, and evaluating the results of the inspection and assessing and collecting the 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.
You should respond in writing within fifteen (15) working days from receipt of this letter. Your response should outline the actions you plan to take in response to this letter, including an explanation of each step being taken to correct the current violations and prevent their recurrence. Include any documentation necessary to show that correction has been achieved. If you cannot complete corrective action within fifteen (15) working days, state the reason for the delay and the time within which you will complete the corrections.
If you have any questions regarding this letter, please contact Ms. Pearl Gonzalez, Compliance Officer, at (407) 475-4730, or via e-mail at email@example.com.
Ramon A. Hernandez
Acting, Director San Juan District
Program Division Director OHAFO IV East