| Public Health Service Food and Drug Administration |
| Los Angeles District Pacific Region 19701 Fairchild Irvine, CA 92612-2506 Telephone: 949-608-2900 FAX: 949-608-4415 |
Department of Health and Human ServicesWARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
W/L 25-10
June 7, 2010
Checchino Massullo, President
Mamma Lina's, Inc.
6491 Weathers Pl
San Diego, CA 92121-2935
Dear Mr. Massullo:
We inspected your seafood processing facility, located at 6491 Weathers Pl, San Diego, California from March 30 through April 1, 2010. 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 Lobster Ravioli, Seafood Ravioli and Argentinean Style Tuna filled Empanadas 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.
We acknowledge the receipt your faxed response to the FDA 483 on April 19, 2010. We address your response below, in relation to each of the noted violations.
Your significant violations were as follows:
1. 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 revised HACCP plan for Lobster Ravioli and Seafood Ravioli provided in response to the FDA 483 issued at the close of the inspection does not list the monitoring frequency at the post cooking cool down critical control point to control the hazard of Staph aureus growth and toxin formation. Your response does not adequately address this violation. Your revised HACCP plan includes a temperature check frequency of at least every (b)(4) hours. However, this monitoring frequency does not correspond to your critical limit of cooling from within (b)(4) from (b)(4) to (b)(4) deg F within (b)(4) and from (b)(4) to (b)(4) deg.within (b)(4). A monitoring frequency (b)(4) is not adequate to monitor your critical limits. To properly monitor the cooling critical limits, a frequency of every (b)(4) is recommended. Additionally, please confirm whether the final critical limit temperature in the plan is (b)(4) as listed, or whether you mean (b)(4).
In addition, your HACCP Time & Temperature Cooking & Cooling Log for March 4, 2009 for Ravioli Batch (b)(4) and (b)(4) reflect a temperature range of (b)(4) to (b)(4) and not from (b)(4) to (b)(4).
2. Because you chose to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b).
a. However, your corrective action plan for Lobster Ravioli and Seafood Ravioli at the "Post cooking/Assembly step metal detection" critical control point to control the hazard of "Metal pieces from mixing/grinding equipment use during production" is not appropriate. Your corrective action plan does not address correcting the cause of the deviation.
b. However, your corrective action plan for Tuna Empanada at the "Assembly step metal detection" critical control point to control the hazard of "Metal pieces from mixing/grinding equipment use during assembly" is not appropriate. Your corrective action plan does not address correcting the cause of the deviation.
c. However, your corrective action plan for Lobster Ravioli and Seafood Ravioli at the "Finished Product Labeling" critical control point to control the hazard of "Undeclared Sulfites in shrimp & lobster" is not appropriate. Your corrective action plan does not address correcting the cause of the deviation.
d. However, your corrective action plan for Tuna Empanadas at the "Finished Product Labeling" critical control point to control the hazard of "Undeclared Sulfites in shrimp & lobster" is not appropriate. Your corrective action plan does not address correcting the cause of the deviation.
Your response does not adequately address this violation.
3. You must implement the record keeping system that you listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(7). However, your firm did not record monitoring observations at the "Finished Product Labeling" critical control point to control "Undeclared Allergens & Food Additives" listed in your HACCP plan for Lobster Ravioli and Seafood Ravioli.
We acknowledge that in your response you provided a revised HACCP plan to include the Records requirement of "Label Review Records Log". However, in order to adequately respond to this deviation, you will need to provide a copy of the completed record for review.
4. You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR Part 110, to comply with 21 CFR 123.11(b). However, your firm did not monitor the (1) safety of water that comes into contact with food or food contact surfaces or used to manufacture ice; (2) prevention of cross-contamination from insanitary objects; (3) protection of food, food packaging material, and food contact surfaces from adulteration; and (4) proper labeling, storage and use of toxic chemicals with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110 as evidenced by:
a. A hose used for cleaning the processing area was stored directly on the floor. A hose located next to the ravioli press lacked a hose bib vacuum breaker and the end of the hose was stored on the floor.
b. An employee's bare forearm was observed in direct contact with ravioli dough while moving pasta into the hopper.
c. An employee was observed cleaning the floor and spraying a hose on a foamy detergent while food items were exposed.
d. A large pump sprayer and a small spray bottle were not labeled and the contents were not identified.
Your response to this violation lacks sufficient detail to evaluate its adequacy. Please provide evidence of employee training and the SSOP's that were covered.
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.
Please send your reply to the Food and Drug Administration, Attention:
Attn: Blake Bevill
Director, Compliance Branch
U.S. Food and Drug and Administration
19701 Fairchild
lrvine, CA 92612-2506
If you have questions regarding any issues in this letter, please contact Marco Esteves, Compliance Officer at 949-608-4439.
Sincerely,
/S/
Alonza E. Cruse
District Director
Los Angeles District
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