| Public Health Service Food and Drug Administration |
| Southwest Region Food and Drug Administration Denver District Office Bldg. 20-Denver Federal Center P.O. Box 25087 6th Avenue & Kipling Street Denver, Colorado 80225-0087 Telephone:. 303-236-3000 FAX: 303-236-3551 |
Department of Health and Human ServicesSeptember 10, 2010
Ref: DEN-10-16 WL
WARNING LETTER
VIA UPS
Mr. Jorge Fierro, Owner/President
Fierro Group
dba Rico Brand
545 West 700 South
Salt Lake City, Utah 84101-2228
Dear Mr. Fierro:
We inspected your seafood processing facility, located at 545 West 700 South, Salt Lake City, Utah, on June 7-8, 10, 2010. We found that you have violations of the seafood Hazard Analysis and Critical Control Points (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 to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of 21 CFR 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). Accordingly, your shrimp ceviche is adulterated, in that it has 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.
Your significant 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 process 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 reasonable likely to occur, to comply with 21 CFR 123.6(a) and (b). However, your firm does not have a HACCP plan for shrimp ceviche to control the food safety hazard of pathogen growth and toxin formation, including potential Clostridium botulinum toxin formation..
2. You must maintain sanitation control records that, at a minimum, document monitoring and corrections set out in 21 CFR 123.11(b), t6 comply with 21 CFR 123.11(c). However, your firm did not maintain sanitation monitoring records for safety of water, prevention of cross contamination from insanitary objects, maintenance of hand washing, hand sanitizing, and toilet facilities; protection of food, food packaging material, and food contact surfaces from adulteration; proper labeling, storage and use of toxic chemicals; and control of employee health conditions required for the processing of shrimp ceviche and/or sanitation corrections for any of the above areas of sanitation. Specifically, you do not have any sanitation monitoring records for your ready-to-eat shrimp ceviche.
3. 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 three of the eight steps of sanitation with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR 110. For example:
Prevention of cross-contamination from insanitary objects:
• When the towels used to wipe, rinse, and sanitize the processing room tables came in contact with the floor, the cleaning employee would wring the moisture out of the towels and continue to clean without sanitizing the towels.
• Employees were observed leaving the processing/packaging room and returning to processing activities without washing their hands.
• Employee smock sleeves were coming in contact with in-process products such as raw shrimp and chopped vegetables.
• On 6/7-8/2010, towel sanitizer buckets in the processing room did not have a measurable concentration of quaternary sanitizer solution. The cloth towels used to wipe processing tables were used without being stored or rinsed in the sanitation buckets.
Proper labeling and storage of chemicals:
• Bottles containing various cleaning solutions were observed throughout the plant. The bottles did not bear labels indicating the contents of the bottles.
Exclusion of pests:
• The plastic covering, surrounding a ventilation pipe located above the east facing rolling warehouse door, was torn leaving an opening to the outside of the building.
• The north rolling warehouse door contains a gap greater than 1/4 of an inch at the bottom of the door leading to the outside.
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 plans and sanitation monitoring 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: Carolyn A. Pinney, Compliance Officer, at the above letterhead address. If you have any questions regarding any issue in the letter, please contact Carolyn A. Pinney at (303) 236-3024.
Sincerely,
/s/
H. Thomas Warwick, Jr.
Denver District Director
HTW/cap
No comments:
Post a Comment