Inspections, Compliance, Enforcement, and Criminal Investigations

Compania Pesquera Charly, SA dba Copescharly, SA 1/5/17

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 College Park, MD  20740 

 

January 5, 2017                                              
WARNING LETTER
 
VIA EXPRESS DELIVERY
 
Mr. Carlos Goff Amador
General Manager
Compania Pesquera Charly, SA dba Copescharly, SA
Barrio Sandino Calle al INHCO
Puerto Cabezas, Atlantico Norte
Nicaragua
 
Reference number: 509797
 
Dear Mr. Amador:
 
The U.S. Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility, Compania Pesquera Charly, SA dba Copescharly SA, located at Barrio Sandino Calle al INHCO, Puerto Cabezas, Puerto Cabezas, Atlantico Norte, Nicaragua on June 9-10, 2016.  During that inspection, we found you had serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Titled 21, Code of Federal Regulations, Part 123 (21 CFR 123). At the conclusion of the inspection, the investigator issued an FDA-483, Inspectional Observations, listing the deviations found at your firm.
 
We acknowledge receipt of your response received via email on September 3, 2016, which included a revised HACCP plan and supporting documentation. However, our evaluation of the documentation revealed that the response was not adequate, as further described in this letter.
 
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 Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4).  Accordingly, your sea cucumber products are adulterated, in that 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 FDA’s 4th Edition of the Fish and Fisheries Products Hazards & Controls Guidance (the Hazards Guide) through links in FDA's home page at www.fda.gov.
 
We note the following significant deviations:
 
1.    You must have a HACCP plan that, at a minimum, lists the critical limits that must be met, to comply with 21 CFR 123.6(c)(3). A “critical limit” is defined in 21 CFR 123.3(c) as "the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard." However, your firm’s revised HACCP plan for “Dry Salted Sea Cucumber without Innards” does not list a critical limit for water activity (Aw) to control pathogen growth and potential toxin formation in your shelf stable products. Products that are dried and/or salted and intended to be held at ambient room temperature (i.e., not intended to be held under refrigeration) need to achieve a final Aw of 0.85 or below to ensure the safety of the products. This value should be listed in your HACCP plan, and your plan should include critical control points necessary for achieving this final Aw value.  For example,
 
a.  At the “(b)(4) Boiling in Salmuera” critical control point your plan lists “(b)(4)”, however, to adequately assure that your dried sea cucumbers attain a safe water activity (i.e., 0.85 or below), your plan should include critical limits for the salinity of the water and the cook time.
 
b.  At the “(b)(4)” critical control point your plan lists “(b)(4)”, however in addition to the drying temperature, FDA recommends listing critical limits for the oven processing step which include all of the following critical factors as established by a scientific study to ensure the finished product has an Aw of 0.85 or below:
 
i.  drying time;
ii.  input / output air temperature;
iii.  cucumber size; and
iv.  other critical factors that affect the rate of drying of the product.
 
c.  At the “(b)(4)” critical control point your plan lists “(b)(4)”, however, because documentation in your response states “(b)(4)”, your plan needs to ensure that the products are held below 10°C during this dehumidifier step to control pathogen growth, including Staphylococcus aureus growth and toxin formation.  This is critical because you have not established that your product reaches a safe Aw (i.e., 0.85 or below) during the previous “(b)(4)” drying step. Consequently, we recommend that at this dehumidifier processing step that the product is held at temperatures below 10°C until the flesh of the sea cucumber reaches a safe water activity.  In addition, you should conduct studies to establish minimum time necessary for the products to reach an Aw of 0.85.  Conversely, if the product reaches an Aw of 0.85 at the “(b)(4)” critical control point, that should be listed as a critical limit at that step and refrigeration will not be necessary at the “Dehumidifier” critical control point.
 
2.    You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequencies for each critical control point to comply with 21 CFR 123.6(c)(4). However, your firm’s revised HACCP plan for “Dry Salted Sea Cucumber without Innards” lists monitoring procedures / frequencies that are inadequate to control pathogenic bacteria growth and toxin formation.
 
a.  Your monitoring procedure and frequency at the “(b)(4)” critical control point states that you will monitor boiling water temperature using a (b)(4), during each boiling.  However, FDA recommends using a continuous temperature-recording device to measure the temperature of the cooking equipment at the cold spot of the equipment, and a visual observation of temperature at least once per batch. Your firm also has the option of visually monitoring the start and finish of a rolling boil of the water instead of continuously monitoring the temperature.
 
b.  Your monitoring procedure and frequency at the “(b)(4)” critical control point states that you will use a (b)(4) to monitor the oven temperature.  FDA recommends that in addition to continuously monitoring the oven temperature, that you also do a visual check of the recorded data at least once per batch or lot.
 
3.    Because you chose to include a corrective action plan, your described corrective actions must be appropriate to comply with 21 CFR 123.7(b).  However, your corrective action plan for “Frozen Whole Sea Cucumber” is not appropriate to control pathogenic bacteria growth and toxin formation.  Specifically, your corrective action for your pre-boiled frozen sea cucumber at the “(b)(4)” critical control point lists “(b)(4).”  This corrective action will not control the hazard of preformed S. aureus toxin which is heat stable and will not be controlled during your boiling or drying process.  FDA recommends rejecting the lot or diverting it for non-food use. 
 
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. More specifically, your response should include documentation and information that would assist us in evaluating your corrections, such as a revised HACCP plan and 5 days of monitoring records. If you cannot complete all corrections within 15 days, you should explain the reason for your delay and state when you will correct any remaining violations.
 
If you do not respond or if we find your response inadequate, we may take further action. For instance, we may take further action to refuse admission of your imported sea cucumber products under Section 801(a) of the Act (21 U.S.C. § 381(a)), including placing them on detention without physical examination (DWPE). FDA’s DWPE is an administrative procedure whereby products offered for import into the United States may be detained without physical examination upon entry. DWPE information may be conveyed in FDA’s Import Alerts. For your information, an example of an Import Alert that conveys information specific to foreign firms that are not in compliance with the seafood HACCP regulations is Import Alert #16-120. This alert can be found on FDA’s web site at: www.accessdata.fda.gov/cms_ia/ialist.html.
 
This letter may not list all the deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act and all applicable regulations, including the seafood HACCP regulation and the Good Manufacturing Practice regulation (21 CFR 110).  You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations. 
 
Additionally, 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 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 U.S.C. § 379j-31(a)(2)(B)). For a foreign facility, FDA will assess and collect fees for re-inspection-related costs from the U.S. Agent for the foreign 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. Please consider providing a copy of this letter to your U.S. Agent.
 
Please send your reply to the Food and Drug Administration, Attention: Sheena Crutchfield, Compliance Officer,Office of Compliance, Division of Enforcement, 5001 Campus Drive, College Park, MD 20740 U.S.A. If you have any questions regarding this letter, you may contact Sheena Crutchfield via email at Sheena.Crutchfield@fda.hhs.gov.  Please reference CMS#509797 on any submissions and within the subject line of any emails to us. 
 
Sincerely,
/S/ 
William A. Correll, Jr.
Director
Office of Compliance
Center for Food Safety
and Applied Nutrition

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