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  5. Southern Coast Enterprises - 547377 - 05/25/2018
  1. Warning Letters

WARNING LETTER

Southern Coast Enterprises MARCS-CMS 547377 —

Delivery Method:
United Parcel Service
Product:
Food & Beverages
Recipient:
Recipient Name
Darren B. Lickliter
Recipient Title
Owner
Southern Coast Enterprises

10409 Tucker Road
Ocean Springs, MS 39565-7919
United States

Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)

6751 Steger Drive
Cincinnati, OH 45237
United States

May 25, 2018

WARNING LETTER 547377


Dear Mr. Lickliter:

On January 9-23, 2018, the U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 10409 Tucker Road, Ocean Springs, Mississippi, where you manufacture pickled quail eggs, which are acidified foods. The inspection revealed serious violations of the regulations for acidified foods [Title 21, Code of Federal Regulations, Part 108, Emergency Permit control (21 CFR 108) and Part 114, Acidified Foods (21 CFR 114)]. Accordingly, we have determined your acidified food products are adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 United States Code (USC) 342(a)(4)], because they have been 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, your “Hot & Spicy Quail Eggs” are misbranded within the meaning of Section 403(k) and 403(i)(2) of the Act. You can find the Act and applicable regulations through links in FDA’s Internet homepage at www.fda.gov.

As a manufacturer of acidified food products, you are required to comply with the Food, Drug and Cosmetic Act (the Act) and the federal regulations relating to the processing of acidified food products. The Emergency Permit Control regulations were issued, in part, pursuant to Section 404 of the Act, Emergency Permit Control, 21 USC 344. A temporary emergency permit may be required for thermally processed low-acid foods packaged in hermetically sealed containers and acidified foods whenever a processor has failed to fulfill the requirements of 21 CFR 108.25, including registration and filing of process information, and the mandatory requirements in 21 CFR 114. Regulations specific to the processing of acidified food products are described in 21 CFR 108 and 21 CFR 114. As outlined in these regulations, a commercial processor that does not adhere to all of the mandatory requirements of 21 CFR 108.25 and 21 CFR 114 could be subjected to an immediate application of the emergency permit control provisions of Section 404 of the Act (21 USC 344). Violation of the mandatory requirements set forth in 21 CFR 108.25 and 21 CFR 114 renders your acidified food products adulterated within the meaning of Section 402(a)(4) of the Act, 21 USC 342(a)(4).

We acknowledge receipt of your written response dated February 7, 2018, to the FDA 483 observations; however, your firm’s corrective actions taken in response to the violations are inadequate to address our concerns, as further described below.

Acidified Food Violations:

During the January 9-23, 2018 inspection, FDA investigators observed the following significant violations, which were listed on a FDA 483, Inspectional Observations, and issued to you on January 23, 2018:

1. Your firm failed to provide the FDA, before packing any new product, information on the scheduled process from a qualified processing authority filed with FDA for your finished product labeled as “Hot & Spicy Quail Eggs”, as required by 21 CFR 108.25(c)(2). Specifically, there is no scheduled process on file for this product. In addition, your firm is not registered as an acidified food processor in accordance with 21 CFR 108.25(c)(1).

As a commercial processor engaged in the thermal processing of acidified foods, you must provide the FDA information as to the scheduled processes, including conditions for heat processing and control of pH, salt, sugar, and preservative level and source and date of the establishment of the process, for each acidified food in each container size, as required by 21 CFR 108.25(c)(2).

Your February 7, 2018, response identifies a process authority who is working on the scheduled process to be submitted to FDA. Your response is not adequate as there is no scheduled process currently on file with FDA and no evidence was provided to substantiate your claims.

2. Your firm failed to employ appropriate quality control procedures to ensure that finished foods do not present a health hazard as required in 21 CFR 114.80(a). Specifically, there is no assurance of the amounts of raw ingredients added to the brine solution, and no assurance the brine and acid solutions are adequate to produce the finished product. In addition, the start and finish cook times are not included on batch records and there is no assurance of the actual pH of the finished products because the buffer solutions used were expired.

Your response indicated you have purchased new buffer solutions for the pH meter; however, you did not provide evidence to substantiate your buffer purchase, the employment of a proper process authority, or the promised new batch records to record the required information per the regulations. In addition, there is no documentation of the finished product pH testing results and there is no assurance the pH meter is working properly with expired buffer solutions used for calibration. There is also no documentation of the thermometer calibration.

3. Your firm failed to comply with the criteria in the Current Good Manufacturing Practice (CGMP) Regulation (21 CFR 110) as required by 21 CFR 114.5. Specifically, our investigator noted that your firm does not provide employees with readily accessible and adequate toilet facilities, as required by 21 CFR 110.37(d).

Your response indicated a restroom is available in another building. This is inadequate, as your firm must have adequate toilet facilities readily accessible to employees and toilet facilities in another building is not readily accessible. The facilities need to be in the same building as which you operate.

4. Your firm failed to mark each container with an identifying code specifying the product contained therein, year, date and packing period, as required by 21 CFR 114.80(b). Specifically, your product code does not reflect the required components and is not unique to the manufactured batch or lot.

We acknowledge your response provided an example of a lot code with an expiration date. Please provide information about how that code was derived. The required identification shall specify in code the establishment where the product was packed, the product contained therein, and the year, day, and period during which it was packed.

Misbranding Violations:

1. Your “Hot & Spicy Quail Eggs” product is misbranded within the meaning of Section 403(k) of the Act [21 USC 343(k)] because the product bears or contains an artificial coloring, but does not bear labeling stating that fact. Specifically, your product labels fail to declare the artificial color FD&C Yellow #5 by its listed name or an appropriate abbreviation, as required under 21 CFR 101.22(k).

2. Your “Hot & Spicy Quail Eggs” product is misbranded within the meaning of Section 403(i)(2) of the Act [21 USC 343(i)(2)] because it is fabricated from two or more ingredients but each ingredient is not declared on the label, as required by 21 CFR 101.4. For example, your product is manufactured using (b)(4); however, you fail to declare these ingredients on your product label.

Furthermore, we note that under 21 CFR 101.4, the grouped ingredient “distilled vinegar & water” is not an appropriate common or usual name for the ingredients distilled vinegar and water; therefore, each added ingredient should be listed separately. Based on the ingredient list provided, water was not an added ingredient. Additionally, based on the ingredient list provided, no other additional spices were added to the product, other than those already declared on the product label. Therefore, it appears that “water” and “spices” should not be declared within the product’s ingredient statement.

The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to assure your firm complies with all requirements of federal law and FDA regulations. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and/or injunction.

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 reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection which 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 administration expenses incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees [21 USC 379j-31(a)(2)(B)]. 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 reinspection-related costs. You are requested to notify this office in writing within 15 working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again.

Include documentation of the corrective actions you have taken. If your planned corrections will occur over time, please include a timeframe for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time in which the corrections will be completed.

Please send your reply to Kari L. Batey, Compliance Officer, U.S. Food and Drug Administration, 404 BNA Drive, Nashville, TN 37217. Any questions you may have regarding this process should be directed to Ms. Batey at (615) 366-7808.

Sincerely,

/S/
Steven B. Barber
Director, Division V
Office of Human and Animal Foods Operations-East

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