Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cali-rice-valley-inc-605184-05292020
Timestamp: 2020-08-12 13:14:33
Document Index: 372100138

Matched Legal Cases: ['art 117', 'art 117', '§ 342', 'art 117', '§ 331', 'art 123', 'art 123', 'art 123', '§ 342', '§ 342', '§379', 'art 101', '§ 343', '§ 117', '§ 117', '§ 117']

Cali Rice Valley Inc. - 605184 - 05/29/2020 | FDA
Cali Rice Valley Inc. - 605184 - 05/29/2020
Cali Rice Valley Inc. MARCS-CMS 605184 — May 29, 2020
Mr. Cuong T. Do
1950 Innes Ave, Suite 5
WL 605184
Dear Mr. Do:
The United States Food and Drug Administration (FDA) inspected your seafood processing and noodle manufacturing facility, located at 1950 Innes Ave, Suites 4-7 and 9-13, San Francisco, CA, on November 19, 20, 25, December 3, 10, 11, 31, 2019, and January 6, 14, and 21, 2020. During our inspection of your facility, FDA investigators observed serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). Based on FDA’s inspectional findings, we have determined that the ready-to-eat (RTE) rice noodles and wheat noodle products manufactured in your facility are 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)] because they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or whereby they may have been rendered injurious to health. In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (located in subparts A, C, D, E, F, and G of part 117) is prohibited by section 301(uu) of the Act [21 U.S.C. § 331(uu)]. You may find the Act and further information about the CGMP & PC rule through links on FDA's website at http://www.fda.gov.
We also found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, [Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 123)]. In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products adulterated within the meaning of section 402(a)(4) of the Act [21 U.S.C. § 342(a)(4)]. Accordingly, your RTE Rice Valley brand Shrimp Rice Rolls are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You can find the Act, the seafood HACCP regulation, the Fish and Fisheries Products Hazards & Controls Guidance and FDA regulations through links on FDA’s website at http://www.fda.gov.
In addition, your Instant Noodles and Ready Cooked Noodles products are also adulterated under section 402(c) of the Act [21 U.S.C. § 342(c)] because they contain color additives which are unsafe within the meaning of section 721(a) of the Act [21 U.S.C. §379e(a)].
Further, we found significant violations of the labeling regulations for foods, 21 CFR Part 101. These violations cause your products described below to be misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343].
To date we have not received a response to the FDA Form-483.
facility will not be adulterated under Section 402 of the Act or misbranded under section 403(w) of the Act [21 CFR § 117.135(a)(1)]. Preventive controls include, as appropriate to the facility and the food, process controls, food allergen controls, sanitation controls, supply‐chain controls, and a recall plan (see 21 CFR § 117.135). Preventive controls are subject to preventive control management components as appropriate to ensure the effectiveness of the preventive controls, taking into account the nature of the preventive control and its role in the facility's food safety system (see 21 CFR § 117.140).
This letter is not intended to be an all-inclusive list of the violations that may exist at your facility or about your products. It also does not indicate that FDA has conducted an all-inclusive review of all the products you manufacture and/or distribute. It is your responsibility to ensure the products you manufacture and/or distribute are following all applicable statutes and regulations, including the Act and applicable FDA regulations. You should take prompt action to correct all the violations noted in this letter and establish and implement procedures that will prevent the recurrence of these violations and the occurrence of other violations. Failure to correct and prevent these violations, or similar ones, may result in FDA taking regulatory action, including, without limitation, seizure or injunction.
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 reinspection-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. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees [21 U.S.C. 379j-31(a)(2)(B)].
For a domestic facility, FDA will assess and collect fees for reinspection-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 to 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 reinspection related costs.
Please send your written response to the attention of:
Refer to Unique Identification Number #605184 when replying.
If you have questions regarding this letter, please contact Elodie Tong-Lin, Compliance Officer, at elodie.tong-lin@fda.hhs.gov or 510-337-6870 .
District Director | FDA San Francisco District
Office of Human and Animal Food Operations –West Division 5