Blends Maker Mfg Inc. 8/28/12
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
San Juan District
466 Fernandez Juncos
San Juan, Puerto Rico 00901-3223
RETURN RECEIPT REQUESTED
Mr. Antonio José Lázaro Santos
Blends Maker Manufacturing, Inc.
PMB 274 P.O. Box 4985
Caguas, Puerto Rico 00726
Dear Mr. Lázaro Santos:
The Food and Drug Administration (FDA) inspected your juice and juice beverage manufacturing facility located at Road 780 km 4.6 Sector Lozano, Barrio Doña Elena, Comerio, Puerto Rico 00782 on January 18, 23, February 2, and April 12, 27, 2012. We found that you have serious repeat violations of the juice Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations (CFR), Part 120 (21 CFR 120). In accordance with 21 CFR 120.9, failure of a processor of juice products to have and implement a HACCP plan to operate in accordance with the requirements of 21 CFR 120, shall render the juice products adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act).
During the inspection of your facility, product labels for your juices and juice beverages were collected. We have reviewed your product labels and found that your labels cause your products to be adulterated within the meaning of section 402(a)(2)(C)(i) of the Act and misbranded according to section 403 of the Act. We also found that your products are not labeled in accordance with Title 21 CFR Part 101, Food Labeling regulation.
You may find the Act, the juice HACCP regulation and the Food Labeling regulations through links in FDA’s home page at http://www.fda.gov
Your significant HACCP violations were as follow:
1. You must have a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 120.8(a). However, you do not have a HACCP plan for your 100% juice, (b)(4), that is manufactured by your firm. Furthermore, you do not have a written hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur, and to identify control measures that you can apply to those hazards.
We further advise that additional juice and juice concentrate products processed by your firm may be subject to the regulatory requirements of 21 CFR Part 120 because they are 100% juice. We suggest that your firm conduct a thorough hazard analysis of all your juice and juice products to assess whether are subject to the juice HACCP regulation and would therefore require HACCP plans.
2. You must perform a 5-log reduction of the pertinent microorganism(s) in your (b)(4) concentrate to comply with 21 CFR 120.24(a). This 5-log reduction and final product packaging must be accomplished in your facility through treatment applied directly to the juice to comply with 120.24(b) and (c). Your firm should also assess during your hazard analysis whether additional juice and juice products processed by your firm require the 5-log reduction to comply with 21 CFR 120.24(a), (b), and (c).
3. You must have and implement a Sanitation Standard Operating Procedure (SSOP) that addresses the eight critical points of sanitation conditions and practices before, during, and after processing in accordance with 21 CFR 120.6(a). In addition, you must adequately monitor sanitation conditions and practices with sufficient frequency to ensure conformance with Current Good Manufacturing Practices regulation to comply with 21 CFR 120.6(b). However, your firm does not monitor safety of water, condition food contact surfaces, prevention of cross-contamination and pest control as evidenced by the observations listed in the FDA-483 (1/18/2012-04/27/2012).
Your significant labeling violations were as follow:
1. Your fruit juice products are adulterated within the meaning of section 402(a)(2)(C)(i) of the Act [21 U.S.C. § 342(a)(2)(C)(i)] in that they bear or contain a food additive that is unsafe within the meaning of section 409 of the Act [21 U.S.C. § 348]. Section 409(a)(2) deems a food additive to be unsafe unless its use conforms with a regulation prescribing the conditions of safe use. Under 21 CFR 172.804(d)(2), a condition of safe use for the food additive aspartame is that aspartame containing product labels bear the statement “PHENYLKETONURICS:CONTAINS PHENYLALANINE”. For example, your “Bebida de Jugo de Tamarindo 1+4”, “Aloha Punch 1+4” and “Uva Concentrate products contain aspartame as a sweetener, but the labels fail to bear the statement “PHENYLKETONURICS:CONTAINS PHENYLALANINE” on the principal display or information panel.
2. Your Tropical Sunrise Caribbean Mojito Concentrate for Blender (1/2 gallon), Bebida de Jugo de china 1 +4 (3.5L), and Tropical Sunrise Parcha 1 +4 (3.5L) products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the products purport to be beverages containing fruit juice, puree, pulp or concentrate, but the labels fail to bear a percent juice declaration as required by 21 CFR 101.30.
3. Your Tropical Sunrise Parcha 1 +4 (3.5L) product is misbranded within the meaning of Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9. For example:
• The Total Fat content is not declared as required by 21 CFR 101.9(c)(2).
• The Saturated Fat content is not declared as required by 21 CFR 101.9(c)(2)(i).
• The Trans fat content is not declared as required by 21 CFR 101.9(c)(2)(ii).
• The Cholesterol content is not declared as required by 21 CFR 101.9(c)(3).
4. Your Bebida de Jugo de china 1 +4 (3.5L) and Tropical Sunrise Parcha 1 +4 (3.5L) products are misbranded within the meaning of section 403(f) of the Act [21 U.S.C. § 343(f)] because the product labels contains information in two languages but does not repeat all the required label information in both languages. In accordance with 21 CFR 101.15(c), if a product label contains any representation in a foreign language or foreign characters, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language.
We acknowledge receipt of your response letter received on February 23, 2012, responding to the objectionable conditions cited in the areas of Juice HACCP (21 CFR 120) and current Good Manufacturing Practices (21 CFR 110). However, we have determined that your response is inadequate in that, although some corrections to the observations listed under our FDA-483 Form, Inspectional Observations seem to adequately correct the deficiencies, no records or effective date for the completion and implementation of the corresponding HACCP plan, 5-log reduction processes, and a complete implementation and monitoring of the Sanitation Standard Operating Procedure (SSOP) were provided. In addition, your response did not include any reference concerning labeling deviations noticed in your products that were discussed with you during the course of the inspection and at the discussion with management meeting. You were previously notified of your failure to comply with the Juice HACCP and Food Labeling requirements during our previous inspection of October 2010.
This letter may not list all the deviations at your establishment. You are reminded that it is your responsibility to ensure that your firm operates in compliance with the juice HACCP regulation (21 CFR Part 120), the current Good Manufacturing Practices for foods (21 CFR Part 110) and Food Labeling regulation (21 CFR Part 101).
During our review we also noted the following:
• Several of your fruit juice products contain sodium benzoate. In accordance with 21 CFR 101.22(j), the label of a food to which a chemical preservative has been added shall bear a declaration of both the common or usual name of the ingredient and a separate description of its function, e.g. “to promote color retention.” If sodium benzoate is being used as a preservative, you must declare both the ingredient and the function of the ingredient in the ingredient statement.
• Your Strawberry Concentrate product contains "natural and artificial strawberry flavor.” In accordance with 21 CFR 101.22(i)(2), if the food contains any artificial flavor which simulates, resembles or reinforces the charactering flavor (in this case, strawberry), the name of the food on the principal display panel must be accompanied by the common or usual name of the characterizing flavor and the name of the characterizing flavor must be accompanied by the word(s) "artificial" or "artificially flavored,” e.g., "Artificial Strawberry Concentrate.”
You should take prompt action to correct these violations and to implement procedures whereby such violations do not recur. Failure to do so may result in regulatory action without further notice. These actions include, but are not limited to, seizure and injunction.
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 include in your response documentation such as your HACCP Plan, copies of your Sanitation Standard Operating Procedure, copies of the revised labels for the products that your firm manufactures and distributes, or other useful information that would assist us in evaluating your corrections. If you can not complete all corrections before you respond, this agency expects that you will explain the reason for your delay and state when you will correct any remaining violations.
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 re-inspection and assessing and collecting the re-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.
Your written reply to these concerns should be directed to the Food and Drug Administration, attention: Carlos A. Medina, Compliance Officer, at 466 Fernández Juncos Avenue, San Juan, Puerto Rico 00901-3223. If you have any questions regarding any issue in this letter, please contact Mr. Medina at (787) 474-9538 or via email at firstname.lastname@example.org.
San Juan District