Inspections, Compliance, Enforcement, and Criminal Investigations
Eastern Treats Inc. 04-May-05
Department of Health and Human Services
Public Health Service
VIA CERTIFIED MAIL
May 4, 2005
Chong K . Shin, President and Owner
Eastern Treats Inc.
5626 Hansel Avenue
Orlando, Florida 32809
Dear Mr. Shin:
We inspected your firm, located at the above address, on December 21, 2004 through January 4, 2005 and found that you have serious deviations from the seafood Hazard Analysis and Critical Control Points (HACCP) Regulations, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 123). In accordance with 21 .CFR 123 .6(g), the failure of a processor to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of this part renders the 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 products, including your crab cakes, small shrimp spring rolls, shrimp cigar rolls/shrimp star rolls, shrimp kabobs and coconut shrimp, are adulterated in that they 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 Regulations through links in FDA's home page at www.fda.gov.
The deviations were as follows:
1. You must implement the monitoring procedures that you have listed in your HACCP plan, to comply with 21 CFR 123 .6(b). However, your firm did not follow the monitoring procedure of measuring the "hydrated batter mix temperature" at the batter mix critical control point (CCP) to control the hazard of pathogen growth and toxin formation from Staphylococcus aureus, listed in your HACCP plan for Coconut Shrimp. Specifically, your firm failed to perform any temperature monitoring during batter operations.
2. You must implement the record keeping system that you listed in your HACCP plan, to comply with 21 CFR 123 .6(b). However, your firm did not record monitoring observations at each critical control point to control food safety hazards listed in your three HACCP plans which cover the following products:
a."Crab Cake-Can Pasteurized";
b. Small Shrimp Spring Rolls; and
c. Shrimp Cigar Rolls, Shrimp Kabobs, and Coconut Shrimp products.
Specifically, you failed to establish monitoring records/forms and implement any recordkeeping for monitoring observations at each CCP. During our inspection, no written monitoring records were provided for these three HACCP plans.
3. You must have a HACCP plan that, at a minimum, lists monitoring procedures for each critical control point, to comply with 21 CFR 123.6 (c) (4). However, your firm's HACCP plan for refrigerated "Crab Cake- Can Pasteurized" lists a monitoring procedure at the Receiving critical control point that is not adequate to control the food safety hazards of pathogen growth and toxin formation, specifically Clostridium botulinum.
Your plan lists that you will monitor the delivery truck temperature which will be checked with a probe thermometer. FDA does not consider a temperature check at receiving to be an adequate method of assuring that RTE products, such as refrigerated canned pasteurized crabmeat, were maintained at safe temperatures throughout transportation. For products that are shipped without cooling media or with media that does not completely surround the product, FDA recommends that your firm require some method of continuous temperature monitoring throughout transportation to assure that those products have been maintained at safe temperatures throughout shipment. An example of adequate control is transportation records that show that the fish were held at or below 40°F throughout transit. For shipments received with the transport time being less than 4 hours, you may alternatively choose to monitor the internal temperature of a representative number of containers.
4. You must take an appropriate corrective action when a deviation from a critical limit occurs, to comply with 21 CFR 123.7(a). Sections 123.7(b) and (c) require that a corrective action ensure that no product enters commerce that is either injurious to health or is otherwise adulterated as a result of the deviation and that the cause of the deviation is corrected.
However, your firm took a corrective action when your process for Crab Cake- Can Pasteurized deviated from your critical limit at the Storage critical control point that was not adequate to control pathogen growth and toxin formation, specifically Clostridium botulinum. From October 2003 to October 2004, your Temperature Recording Device periodically recorded temperatures over 40°F and routinely failed to operate properly. Your corrective action failed to identify and eliminate the cause of the storage temperature exceeding 40°F as demonstrated in the Corrective Action records from October 2003 to October 2004.
5. You must fully document, in records, all corrective actions taken, to comply with 21 CFR 123.7(d). However, you did not document that a corrective action was taken when you deviated from your critical limit of 40°F or less for refrigerated "Crab Cake-Can Pasteurized" at the Storage critical control point to control the food safety hazard of pathogen growth and toxin formation, specifically Clostridium botulinum.
Our FDA Investigators observed on December 21, 2004 that the wheel chart records for the Temperature Recording Device in the walk-in cooler have no corrective action documentation on the following dates: 12/29/03-1/5/04,2/23-3/1104,4/26-5/3/04, 5/10/04-5/11/04,8/9-8/16/04 and 9/27-10/4/04 when either temperatures higher than 40°F were observed, or there were no temperatures recorded on the recording chart for the Temperature Recording Device.
Furthermore, the FDA has determined that your facility is subject to the registration requirement in § 415 of the Act and our implementing regulation at 21 CFR Part 1, Subpart H. During our current inspection at your facility on December 21, 2004 through January 4, 2005, you were advised of this requirement. The failure to register a facility as required is a prohibited act under Section 301 of the Act. Our records indicate that, to date, your facility has not been registered with FDA. We request that you, as the Owner and President, register the facility with FDA within 30 working days of the date of this letter. Registration may be accomplished online at http://www.access.fda.gov. We encourage the use of electronic registration because it will result in an automatic confirmation of registration and automatic issuance of a registration number. Alternatively, you may contact the FDA Industry Systems Help Desk at 1-800-216-7331 or 301-575-0156 to inquire about mail or fax registration and related forms.
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 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 new or 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 the deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the Seafood HACCP regulations and the Good Manufacturing Practice regulations (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 H . Shambaugh,Compliance Officer, 555 Winderley Place Suite 200 Maitland, Florida 32751. If you have questions regarding any issue in this letter, please contact Ms . Shambaugh at (407) 475-4730.
Emma R, Singleton
Director, Florida District