Inspections, Compliance, Enforcement, and Criminal Investigations
Appetizers And, Inc. 01-Aug-02
300 S. Riverside Plaza, Suite 550 South
Chicago, Illinois 60606
August 1, 2002
RETURN RECEIPT REQUESTED
Mr. George E. King, President
Appetizers And, Incorporated
2555 N. Elston Avenue
Chicago, IL 60647-2003
Dear Mr. King:
On April 1, 2, and 4, 2002, an investigator from the Food and Drug Administration (FDA) conducted an inspection of your facility located at 2555 N. Elston Avenue, Chicago, Illinois. The inspection found that you have serious deviations from/the seafood hazard analysis and critical control point (HACCP) regulations set fob in Title 21, Code of Federal Regulations (21 CFR), Part 123. In accordance with 21 CFR 123.6(g), 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 his part, renders the fishery products adulterated within the meaning of Section 402(a) 4) of the Federal Food, Drug, and Cosmetic Act (the Act). Accordingly, your Tuna Canolli, Tuna Teriyaki Brochette, Uncooked Seafood Brochette, Oyster Rockefeller, Clams Casino, Crispy Scallops, and Crab Brie in Phyllo products are adulterated, in that these products 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 Hazard & Control Guidance through links in FDA?s home page at http://www.fda.gov.
Our determinations and your deviations are as follows:
In regard to your import seafood operation:
- You must have product specifications, which are designed to ensure that the fish and fishery products you import are not adulterated under the Federal Food, Drug, and Cosmetic Act because they may be injurious to health or prepared/ packed, or held under insanitary conditions, to comply with 21 CFR Part 123.12(a)(2)(i). Your firm lacks written product specifications for the "rock crab combination" you import from [redacted].
- You must implement an affirmative step that ensures the fish and fishery products you import are processed in accordance with seafood HACCP requirements, to comply with 21 CFR Part 123.12(a)(2)(ii). Your firm did not perform an affirmative step for "rock crab combination" manufactured by [redacted]
In regard to your domestic seafood operation:
- You must conduct, or have conducted for you, a hazard analysis to determine the food safety hazards that are reasonably likely to occur for your fish products to comply with 21 CFR 123.6(a), and have a HACCP plan that lists those food safety hazards to comply with 21 CFR Part 123.6(c)(l). However, the following hazards are lacking from your plans:
Your firm?s HACCP plans for Tuna Teriyaki Brochette and Uncooked Seafood Brochette do not list the food safety hazard of histamine in the receiving critical control point for fresh (unfrozen) tuna. Additionally, your HACCP plan for Uncooked Seafood Brochette does not list the food safety hazard of sulfites.
Your firm?s HACCP plans for Oyster Rockefeller and Tuna Canolli do not list the food safety hazard of pathogen growth in finished product storage.
Your firm?s HACCP plans for Clams Casino and Oyster Rockefeller do not list the food safety hazard of environmental chemical contaminants in the receiving critical control point.
Your firm?s HACCP plans for Crispy Scallops and Crab Brie in Phyllo do not list the food safety hazard of allergens.
- You must have a HACCP plan that 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." Your firm?s HACCP plan for Clams Casino lists a critical limit of "clams must be cooked to a minimum internal temperature of 145 degrees F" at the "Cooking-clams" critical control point. However, this critical limit is not adequate to control the food safety hazard that you have identified as "pathogen survival." Generally, a minimum time value at your specified temperature is also necessary.
- 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 Crispy Scallops lists a monitoring frequency at the batter critical control point that is not adequate to control the food safety hazard of pathogen growth. The FDA provides guidance in the Fish and Fisheries Products Hazards and Controls Guidance: Third Edition, 2001. It recommends a continuous time/temperature monitoring frequency of the product by use of a digital time/temperature data logger, recorder thermometer or high temperature alarm with 24-hour monitoring.
- Since you chose to include corrective actions in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plan for Crispy Scallops at the batter critical control point to control pathogen growth is not appropriate. In addition to discarding the batter, you must address the correction of the problem.
- You must retain records at your place of business for at least 2 years after the date they were prepared in the case of frozen products to comply with 21 CFR 123.9(b)(l). However, your firm?s record of receipt for fresh clams that were processed into Clams Casino [redacted] on 4/27/01 were not retained for two years. You stated during the inspection that the Accounting Department does not retain records if the raw material is not purchased frequently (month to month).
- You must have sanitation control records that, at a minimum, document monitoring and corrections, to comply with 21 CFR 123.11 (c). However, your firm maintained sanitation control records that are not adequate. Specifically, your "Pre-Op and Operational Report" (Q/C-SSOP-1) does not include the following sanitation conditions that must be monitored in accordance with 21 CFR 123.11 (b); safety of water, condition and cleanliness of food contact surfaces, prevention of cross-contamination, proper labeling of toxic compounds, employees health conditions, and exclusion of pests.
The above is not intended to be an all-inclusive list of deficiencies at your facility. At the conclusion of the inspection, you were issued a Form FDA-483 (copy enclosed), which is a list of our investigator?s observations of deviations noted during the inspection. It is your responsibility to assure that all of your fishery products are processed in compliance with the requirements of the Act, the seafood HACCP regulations (21 CFR Part 123), and the Good Manufacturing Practice regulations (21 CFR Part 110), as appropriate.
You should take prompt action to correct all of the violations noted in this letter. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction.
Please notify this office in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to correct these violations, including an explanation of steps taken to prevent their recurrence. If corrective action cannot be completed within 15 working days, state the reason for the delay and the date by which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.
Your written reply should be sent to Patrick J. Brown, Compliance Officer, at the above address.
Arlyn H. Baumgarten