| Public Health Service Food and Drug Administration |
Waterview Corporate Center Telephone (973) 331-4970 |
Department of Health and Human Services
WARNING LETTER
United Parcel Service
Mr. Michael Conte, Owner/President
Contes Pasta Company, Inc.
310 Wheat Road
Vineland, NJ 08360-9627
11-NWJ-18
Dear Mr. Conte:
We inspected your seafood processing facility, located at 310 Wheat Road, Vineland, NJ from 01/24/11 through 02/16/11. 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, your seafood filled pasta is adulterated, in that it has been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health. During our inspection, we also collected labels of your products. You may find the Act, the seafood HACCP and GMP regulations and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA’s home page at www.fda.gov.
We received your February 24, 2011 response to the FDA-483. We will comment on your response in this letter.
Seafood HACCP Violation:
You must take an appropriate corrective action when a deviation from a critical limit occurs, to comply with 21 CFR 123.7(a). However, your firm did not take a corrective action to control Clostridium botulinum growth and toxin formation when
your process for frozen lobster deviated from your critical limit at the “Thawing” CCP.
Specifically, on 05/20/10, you deviated from your critical limit of “not to exceed (b)(4) at the CCP at “Thawing”, which is included in your HACCP plan(s), entitled “Mezza Luna Lobster Ravioli” and “Heart Shaped Lobster Ravioli”, both approved on 02/12/10. Your “Thawing Log” indicates that the second temperature recorded for frozen lobster meat was (b)(4). Your corrective action states to “Refrigerate immediately and determine if product is safe based on the length of time over (b)(4)”, however, there was no corrective action documented for deviating from the required temperature and no evaluation of product impact, and the lobster meat was used in the manufacturing of lobster ravioli on 05/22/10.
In your February 24, 2011 response you indicate that you reviewed the cold storage monitoring records, however according to the “thawing log”, the product was thawing under cold water at the time.
Labeling Violation:
- Your Heart Shaped Lobster Ravioli (in red dough) product, is misbranded within the meaning of section 403(k) of the Act [21 U.S.C. § 343(k)] because it contains coloring and it fails to bear labeling stating that fact. Under 21 CFR 101.22(k)(1), certified color additives must be individually declared in the ingredient statement by their common or usual names (e.g. FD&C Yellow No. 6, Yellow No. 6). Because Yellow No. 6 is included in the ingredient statement for the Red Food Color used in the manufacture of this product, but was not specifically declared in the ingredient statement, your product is misbranded.
We have reviewed your response and have determined that it is inadequate. While your firm committed to correcting the labeling at the close-out of the inspection, we did not receive the corrected label in your written response.
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.
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.
In your February 24, 2011 response, you indicate that you no longer stage the racks near the cleaning of machinery. We note that we also observed overspray splashing onto utensils and equipment that may result in cross contamination of product.
We have the following comments on your revised HACCP plan for, “HEAT-TREATED BUT NOT FULLY COOKED, NOT SHELF STABLE PRODUCTS (SEAFOOD-FILLED PASTA):
· You list a corrective action, “Plant management may retain, rework and/or impose a strict reprocessing procedure that would ensure an increased log reduction” at the “thaw” CCP. The corrective action refers to a specific procedure in HACCP-FORM -002. However, there is no specific procedure there or anywhere else in your HACCP plan. We recommend that you refer to Chapter 16 of the Seafood HACCP Guide (The Guide) for information that will assist you in developing an adequate cook step for reconditioning product.
· Your corrective actions for the “Fill and Form” and “Label review” CCPs, are inadequate because they do not insure that adulterated or misbranded product will not enter commerce.
· We note that because you have different critical limits at the, “Thaw”, CCP, the “Thaw” CCP is actually two CCPs: “thawing (b)(4)” and “thawing in (b)(4).” Your critical limit for thawing (b)(4), “…no more than (b)(4) hours” at temperatures between (b)(4), or, “…no more than (b)(4)” between (b)(4). The time/temperature parameters included in the critical limit are those listed in the Guide. However, when temperature is the sole barrier to C. botulinum growth and toxin formation, FDA now recommends strict temperature controls, i.e. at, or about 40ËšF throughout storage, processing and distribution. [See Chapter 13, of the Fourth Edition of The Guide.] Your critical limit in the cooler is, “(b)(4)”.
· Our investigator observed that some of the monitoring records were missing. Although you committed to maintain records, you did not send records to demonstrate that you are currently keeping and reviewing them.
Please send your reply to Stephanie Durso, Compliance Officer, located at the Food and Drug Administration, 10 Waterview Blvd, 3rd Floor, Parsippany, NJ 07054. If you have any questions regarding any issues in this letter, please contact Ms. Durso at 1-973-331-4911.
Sincerely,
/S/
Diana Amador-Toro
District Director
New Jersey District
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