Inspections, Compliance, Enforcement, and Criminal Investigations
Burgos Burgos Corp., 12/14/09
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Baltimore District Office|
6000 Metro Drive, Suite 101
Baltimore, MD 21215
Telephone: (410) 719-5454
FAX: (410) 719-5703
December 14, 2009
RETURN RECEIPT REQUESTED
Mr. Hector S. Burgos, Owner
Mr. Manuel Burgos, Co-Owner
Burgos Burgos Corporation dba The Sandwich Lady
12079 Tech Road #3
Silver Spring, MD 20904
Dear Messrs. Burgos:
We inspected your seafood processing facility, located at 12079 Tech Road #3, Silver Spring, MD on October 8, 13 and 14, 2009. 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 (21 CFR 123). 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 tuna salad sandwiches 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: 3rd Edition (the Hazard Guide), through links in FDA's home page at www.fda.gov.
The violations were as follows:
1. You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur, and you must have and implement 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 your ready-to-eat tuna salad sandwiches to control the food safety hazards of pathogen growth and histamine formation.
2. You must adequately monitor sanitation conditions and practices during processing, in order to comply with 21 CFR 123.11 (b). However your firm did not monitor the prevention of cross contamination. Specifically, employees were manufacturing ready-to-eat tuna sandwiches
without protective beard or mustache coverings.
3. You must maintain sanitation control records that, at a minimum document monitoring and corrections to comply with 21 CFR 123.11(c). However, your firm did not maintain sanitation monitoring records required for the processing of tuna salad sandwiches including:
a. The safety of the water;
b. The conditions and cleanliness of the food contact surfaces;
c. The prevention of cross-contamination;
d. The maintenance of hand washing, sanitizing and toilet facilities;
e. The protection of food, food contact surfaces and food packaging materials;
f. The proper labeling, use and storage of toxic chemicals;
g. The control of employee health;
h. The exclusion of pests.
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). 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 U.S. Food and Drug Administration, Attention: Anne Aberdeen, Compliance Officer, 6000 Metro Drive, Suite 101, Baltimore, MD 21215. If you have questions regarding any issues in this letter, please contact Ms. Aberdeen at (410) 779-5134.