Inspections, Compliance, Enforcement, and Criminal Investigations
La Rosa Logistics Inc 14-Jan-03
Department of Health and Human Services
Public Health Service
VIA CERTIFIED MAIL
January 14, 2003
Migdale La Rosa, President
La Rosa Logistics Inc.
1800 N.W. 96th Avenue
Miami, Florida 33172
Dear Mr. La Rosa,
The Food and Drug Administration (FDA) inspected your firm, at the above address on September 4 and 5, 2002 and found that you have serious deviations from the Seafood HACCP regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123). These deviations cause your seafood products, such as canned, pasteurized crabmeat, fresh, refrigerated crabmeat, and scombroid species, to be in violation of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act). In accordance with 21 CFR 123.6(g), your failure to have and implement HACCP plans that comply with this section or otherwise operate in accordance with the requirements of this part renders your seafood products adulterated within the meaning of Section 402(a)(4) of the Act [21 U.S.C. 342(a)(4)]. Accordingly, your pasteurized crabmeat and scombroid fish products are adulterated, in that the products 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. You can find the Act and the Seafood HACCP regulation through links in FDA's home page at www.fda.gov.
The deviations were as follows:
1. You must conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur, and you must have a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (b). However, your firm does not have a HACCP plan for the fresh, refrigerated crabmeat stored at your facility to control the food safety hazard of pathogen growth and toxin formation, specifically Clostridium botulinum.
Our investigation determined that your firm receives and processes unpasteurized ready-to-eat crabmeat that is packaged in containers that limit oxygen; the containers are plastic with a metal lid sealed to the top with a plastic lid covering. Cooked crabmeat packed in sealed containers, without the secondary barrier of pasteurization, should have strict time and temperature controls. FDA recommends temperature critical limits be set at 38° F and that the temperature of the individual containers be monitored by time/temperature indicators affixed to each plastic container.
Less stringent controls can be used for one pound plastic containers that do not limit oxygen exchange (i.e., without a metal or plastic inner lid). The target pathogen in this case is Staphylococcus aureus. An appropriate critical limit is 45° F and although FDA would expect your firm to assure that the product is adequately cooled throughout shipment, it would not be necessary to affix time/temperature indicators to individual containers.
Your firm has the option of either adding these critical limits and controls to your existing plan for canned pasteurized crabmeat or creating a separate plan for these unpasteurized products.
2. 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 CPR 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 Pasteurized Ready to Eat Crabmeat and Histamine Producing Fish lists critical limits, internal temperatures of 40° F or less at the Receiving critical control point that are not adequate to control the listed hazards.
Your firm receives refrigerated ready-to-eat pasteurized crabmeat and raw refrigerated histamine-producing species directly from foreign processors. The products you receive have been in transport in excess of 4 hours. Some of the products are received without cooling media. FDA does not consider internal temperatures a sufficient hazard control for pathogen growth and histamine formation for transport times exceeding 4 hours. For products that are shipped without cooling media or with media that does not completely surround the product, FDA would expect your firm to require some method of continuous temperature monitoring to assure that those products have been maintained at safe temperatures throughout shipment. Examples of an adequate control include temperature data loggers affixed to the containers during shipment or time temperature indicators.
3. You must have a HACCP plan that, at a minimum, lists the monitoring procedures for each critical control point, to comply with 21 CFR 123.6(c)(4).
a) Your firm's HACCP plan for canned pasteurized crabmeat lists monitoring procedures and frequencies that are not adequate to control the food safety hazard of pathogen growth and toxin formation, specifically Clostridium botulinum. Your plan lists that you will monitor cooler temperatures three times each day. FDA does not consider intermittent temperature checks an adequate method of assuring that ready-to-eat products in sealed containers are held at consistently safe temperatures throughout storage. If you store your product under ice, FDA suggests monitoring the adequacy of the ice twice a day. If you choose to monitor the cooler temperature, FDA suggests you install a high temperature alarm or some method of continuous temperature monitoring, such as a temperature data logger.
b) Your firm's HACCP plan for scombroid species lists a monitoring frequency at the Storage critical control point of visual ice/chemical cooling media checks once for every lot. FDA recommends visual checks of cooling media in a representative number of cases at least twice a day. In addition, your firm chose only to monitor the temperature of the cooler and did not record the monitoring observations of ice/chemical cooling media checks. If you choose to only monitor cooler temperatures, FDA recommends that your firm use some method that can assure that the products are continuously maintained at a safe temperature. The methods would be similar to the ones suggested for ready-to-eat pasteurized crabmeat.
We received a response from [redacted] on your behalf, dated September 9, 2002. The response addressed the deviations noted during our most current inspection. We have evaluated that response, in addition to the observations made by our investigator, and determined that the deviations listed in this letter still require correction.
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. In addition, we may not provide certificates to your firm for export of your products to European Union (EU) countries if you do not correct these deviations.
Please 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 deviations. You may wish to include in your response documentation such as revised HACCP plans and completed monitoring records or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, we expect that you will explain the reason for the delay and state when you will correct any remaining deviations.
This letter may not list all of the deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the Seafood HACCP regulation 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 Federal Food, Drug, and Cosmetic Act and all applicable regulations.
Please send your reply to the Food and Drug Administration, Attention: Shari J. Hromyak, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, Florida 32751. If you have questions regarding any issue in this letter, please contact Ms. Hromyak at (407) 475-4730.
Emma R. Singleton
Director, Florida District