Inspections, Compliance, Enforcement, and Criminal Investigations
Cara Donna Provision Company 6/4/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|New England District Office|
One Montvale Avenue, 4th floor
Stoneham, MA 02180
CMS # 398334
UNITED PARCEL SERVICE
June 4, 2013
Mr. Leopold Cara Donna Jr., President
Cara Donna Provisions Co. Inc.
200 Commerce Drive
Braintree, MA 02184
Dear Mr. Cara Donna:
We inspected your seafood processing facility, located at 200 Commerce Drive, Braintree, Massachusetts from April 25, 2013 through May 3, 2013. We found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123, and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 123 & 110). 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, tuna salad and seafood salad products received, stored, and distributed by your firm 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 the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.
Your significant violation was as follows:
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 HACCP plans for tuna salad and seafood salad do not contain critical limits at the “Receiving/Putaway” critical control points which include the continuous monitoring of incoming delivery truck temperatures to ensure received products maintained temperatures at or below 40° Fahrenheit (F) during transit.
2. You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123.6 (c)(4). However, your firm’s HACCP plans for tuna salad and seafood salad do not list continuous monitoring procedures for the storage of these products on your firm’s delivery trucks. Products are loaded onto these trucks as a means of refrigerated storage prior to delivery to customers. Your firm does not maintain continuous monitoring of the temperatures of these trucks to ensure stored products were maintained at temperatures at or below 40° Fahrenheit (F) during storage and transit.
3. Because you chose to include a corrective action plan in your HACCP plans, your described corrective actions must be appropriate to comply with 21 CFR 123.7(b). However, the corrective actions listed on your firm’s tuna salad and seafood salad HACCP plans are inadequate. For example, your firm’s tuna salad and seafood salad HACCP plans’ corrective actions for the critical control points of “Receiving/Putaway” state “Note exceptions on both copies of receiving paperwork, on temperature log and notify Inventory Control Manager before accepting shipment. Notify Operations Manager for investigation and he will contact refrigeration vendor for diagnosis and repair if necessary.” These corrective actions do not resolve how the cause of the deviation will be corrected.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.
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 domestic facility, FDA will assess and collect fees for re-inspection 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 costs.
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. You should include in your response documentation such as HACCP and verification records, 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.
This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the seafood HACCP regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Please send your reply to the Food and Drug Administration, Attention: Todd Maushart, Compliance Officer, One Montvale Ave, Stoneham, MA 02180. If you have questions regarding any issues in this letter, please contact Compliance Officer Maushart at (781) 587-7578
Acting District Director
New England District
Close Out Letter