Mr. William Rodriquez
- Distribuidora La Jugosita, Inc.
Carretera #1, Km. 50.9
- Issuing Office:
- San Juan District Office
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Office of Regulatory Affairs
Office of Human and Animal Food Operations
East Division IV
466 Avenida Fernández Juncos
San Juan, Puerto Rico 00901-3223
Tel: 7/6/201(787) 729-8500
September 1, 2017
17-OHAFOE4-WL-07 / CMS No. 532714
VIA UNITED PARCEL SERVICE
NEXT DAY - SIGNATURE REQUIRED
Mr. William Rodriquez, President
Distribuidora La Jugosita, Inc.
Carretera #1, Km. 50.9
Cidra, Puerto Rico 00739
Dear Mr. Rodriquez:
The U.S. Food and Drug Administration (FDA) inspected your manufacturing facility located in Cidra, Puerto Rico from April 26, 2017 through May 16, 2017 (all dates not inclusive). During that inspection, serious violations of the Juice Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 120, and the Current Good Manufacturing Practice (CGMP) regulation for food, Title 21, Code of Federal Regulations, Part 110, were observed.
Your significant deviations are as follows:
1. Your firm does not perform a 5-log reduction to address the recontamination risk after repacking juice pulp and concentrates as required under 21 CFR Part 120.24 to address microbiological hazards.
We acknowledge receipt of your firm’s written response (the response) dated June 2, 2017, and our review of the response revealed it is inadequate since your firm does not conduct a 5-log pathogen reduction. The product loses the 5-log microbial reduction applied by the manufacturer once it is exposed to microbial recontamination during re-packing of juice concentrate/pulp.
2. You are not monitoring the sanitation conditions and practices adequately and with sufficient frequency in accordance with 21 CFR Part 120.6(b). Specifically, your firm failed to monitor:
- The exclusion of pests;
- The prevention of cross-contamination;
- The protection of food, food packaging material, and food contact surfaces from adulteration;
- The condition and cleanliness of food contact surfaces;
- The document “Record de Control de Sanitización Diaria” [in English: Daily Sanitation Control Record] does not provide for documenting the exact time when the pre-operational and operational sanitation monitoring steps are conducted.
We acknowledge receipt of the response dated June 2, 2017, with proposed corrective actions addressing pest exclusion including installation of insect lamps, and it will be verified during the next inspection. Also, further review of your corrective actions revealed it is inadequate in that your firm did not submit evidence documenting: how the proposed curtains will prevent the ingress of pests such as lizards and cockroaches; employees re-training activities; and corrective/preventive actions for the equipment observed with rust in product contact and non-contact areas.
3. Failure to store raw materials in a manner that protects against contamination and minimizes deterioration in accordance with 21 CFR Part 110.80(a)(1).
Specifically, fruit juice concentrate, pulps, blends, and baskets containing fruit beverage containers were observed stored against the wall in a walk-in cooler located at the front premises of the facility. In addition, the walk-in freezer of your firm was crowded, thus, we were not capable of inspecting the containers held at the unit during the current inspection. Thus, the observed storage conditions do not provide for the proper cleaning of the storage units. This is a repeat observation from the 2011 and 2009 inspections.
Our review of the corrective actions proposed in the response dated June 2, 2017, revealed it is inadequate, since it does not explain the corrective and preventive actions your firm implemented to correct the cited raw material storage deficiencies to protect against contamination.
This letter may not list all the violations at your facility. You are responsible for ensuring that all of your products are in compliance with the applicable statutes and regulations administered by FDA. You should take prompt action to correct these violations. Failure to promptly correct these violations may result in regulatory action by FDA without further notice. Such action includes seizure of your products and/or injunction. If you do not respond or if we find your response inadequate, we may take further regulatory administrative action.
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.
Your reply should be directed to Ms. Maridalia Torres, District Director, Food and Drug Administration, Office of Human and Animal Food Operations, East Division IV, 466 Fernández Juncos Avenue, San Juan, Puerto Rico, 00901-3223. If you have any questions regarding this letter, please contact Ms. Pearl Gonzalez, Compliance Officer, at (407) 475-4730, or via e-mail at firstname.lastname@example.org.
OHAFO, East Division lV