WARNING LETTER
Ocho Rios-Miami, Inc.
MARCS-CMS 616385 —
July 30, 2021
Delivery Method:
VIA Electronic Mail
Reference #:
21-HAFE4-WL-07
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Aston Lue
Recipient Title
Owner
Ocho Rios-Miami, Inc.
9956 SW 155 Court
Miami
,
FL
33196
United States
astonlue@gmail.com
Issuing Office:
Division of Human and Animal Food Operations East IV
United States
WARNING LETTER
7/30/2021
21- HAFE4-WL-07/CMS No. 616385
Dear Mr. Lue:
The United States Food and Drug Administration (FDA) inspected your seafood warehousing and distribution facility located at 3675 NW 71st Street in Miami, FL 33147 on March 29-May 06, 2021, and June 29-July 09, 2021 (dates not all inclusive). Our inspection found you have 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 seafood processor 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 Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4). Accordingly, your seafood products are adulterated because they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and the 4th Edition of the Fish and Fishery Products Hazards and Controls Guidance (the Hazards Guide) through links on FDA's home page at www.fda.gov.
During both inspections of your facility, our Investigators’ observations were noted on a Form FDA- 483, Inspectional Observations, issued to you on May 06, 2021, and July 09, 2021. As of the date of this letter, we have not received your firm’s written notification specifying the corrective actions implemented.
Your significant violations were as follows:
1. You have not conducted or have had conducted for you, a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur in your fish and fishery products.
Hazards associated with Vacuum-packed Split Mackerel include Parasites, Scombrotoxin (Histamine) formation, Pathogenic Bacteria Growth other than C. botulinum due to temperature abuse, and C. botulinum toxin formation. Hazards associated with Salted Cod and Salted Pollack include Parasites and Pathogenic Bacteria Growth other than C. botulinum due to temperature abuse.
2. You do not have written HACCP plans for your refrigerated Vacuum-packed Split Mackerel, Salted Pollack and Salted Cod products to mitigate potential hazards at points of receiving, storage, and distribution.
Every processor shall have and implement a HACCP plan. Once you have conducted a hazard analysis for your seafood products, you must have and implement a written HACCP plan to control those identified hazards that are reasonably likely to occur and have a HACCP plan that at a minimum, lists the appropriate critical control points, critical limits, monitoring procedures, recordkeeping activities, etc., to ensure the food safety hazards are controlled and comply with 21 CFR 123.6(a).
A critical control point is defined in 21 CFR 123.3(b) as a “point, step, or procedure in a food process at which control can be applied and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels.”
3. Your HACCP plan does not list the food safety hazards that are reasonably likely to occur.
Your HACCP plan for Refrigerated Salted Herring and Refrigerated Salted Mackerel does not identify the food safety hazard of Pathogenic Bacteria Growth and Toxin Formation as a result of Time and Temperature Abuse at the Critical Control Points of Receiving and Storage. Additionally, the continuous time-temperature recording device on your Walk in Cooler is not working properly and does not allow you to review the temperatures in the cooler.
Food safety hazards that are reasonably likely to occur should be identified and controlled for each fish and fishery product as outlined under 21 CFR 123.6(c)(1). Consideration should be given to whether any food safety hazards are reasonably likely to occur as a result of Natural toxins; Microbiological contamination; Chemical contamination; Pesticides; Drug residues; Decomposition in scombroid toxin-forming species; or Parasites, where the processor has knowledge or has reason to know that the parasite-containing fish or fishery product will be consumed without a process sufficient to kill the parasites, or where the processor represents, labels, or intends for the product to be so consumed.
4. You do not have or have not implemented written verification procedures and an affirmative step for ensuring that fishery products you import are processed in compliance with the Seafood HACCP regulation, 21 CFR 123.12(a)(2).
Your firm’s Importer Verification Procedure dated September 23, 2014, indicates
(b)(4)
. You currently import Salted Pollock fillets, a product of China, which is packed for a company in Canada. You did not implement your written verification procedures and did not maintain the foreign processor HACCP plan and written guarantee as per your Importer Verification Procedure for the Salted Pollock fillets you import.
This letter is not intended to be an all-inclusive list of violations at your facility or in connection with your products. This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. You are responsible for ensuring that your facility operates in compliance with the Act, the seafood HACCP and sanitation regulations (21 CFR 123), and other applicable laws. Your firm should investigate and determine the causes of the violations and take prompt actions to correct any violations and bring the products into compliance You are responsible for preventing further violations of the Act and all applicable regulations. Failure to adequately address this matter may lead to regulatory action by the FDA without further notice, including, without limitation, seizure and injunction.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific actions you are taking to correct these violations. You should include in your response documentation such as HACCP plans for each type of fish (e.g., Histamine formers) you store and distribute or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations. If you believe that your products are not in violation of the FD&C Act, please provide us with your reasoning and any supporting information for our consideration within fifteen (15) working days.
Section 743 of the Act, [21 USC 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 means 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 USC 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.
Please send your reply to the Food and Drug Administration, to attention of, Mr. Ramon A. Hernandez, Program Division Director, 466 Fernandez Juncos Avenue, San Juan, Puerto Rico 00901. If you have questions regarding this letter, please contact Ms. Laura Kennedy, Compliance Officer, at (813) 915-7948, or via e-mail at: Laura.Kennedy@fda.hhs.gov.
Sincerely,
/S/
Ramon A. Hernandez
District Director, San Juan District Office
Program Division Director,
Office of Human and Animal Food Operations
Division IV East
Content current as of:
08/03/2021
Regulated Product(s)
Food & Beverages