|Company:||Blends Maker Mfg Inc.|
|Issuer:||San Juan District Office|
|Issued:||Aug. 28, 2012||Closed:||
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
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.
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).
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.
• 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.”