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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Sri Lankan Delight, Inc. 3/19/13

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
Los Angeles District
Pacific Region
19701 Fairchild
Irvine, CA 92612-2506
 
Telephone:      949-608-2900
FAX:    949-608-4415 

 

WARNING LETTER
 
 
VIA UNITED PARCEL SERVICE                                                                     
SIGNATURE REQUIRED
 
 
March 19, 2013                                                                                                              
WL# 30-13
Roshan De Silva, Owner & President
Sri Lankan Delight, Inc.
19016 Ventura Blvd
Tarzana, CA, 91356-3214
 
Dear Mr. Silva:
 
We inspected your seafood importer establishment, located at 19016 Ventura Blvd, Tarzana, CA, from January 9 - 29, 2013 We found that you have serious violations of the Hazard Analysis and Critical Control Point (HACCP) regulation for fish and fishery products, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 123). The specific requirements for imported fish and fishery products are set out in 21 CFR Part 123.12. As an importer of fish or fishery products, you must operate in accordance with the requirements of Part 123. In accordance with 21 CFR 123.12(d), there must be evidence that all fish and fishery products offered for entry into the United States have been processed under conditions that comply with 21 CFR Part 123. If assurances do not exist that the imported fish or fishery product has been processed under conditions that are equivalent to those required of domestic processors under 21 CFR Part 123, the fish or fishery products will appear to be adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4) and will be denied entry. Because our inspection identified serious violations for 21 CFR Part 123, your Maldive Fish Sambol, Wet Seeni Sambol, Katta Sambol, Seeni Sambol, Katta Sambol, Red Coconut Sambol Fried Sprats Sambol, Chili Fried Sprats, Bitter Gourd with Sprats, Ambul Thiyal Fish, Dry Seer, Dry Tuna, Dry Badun, and Dry Katta. are adulterated under Section 402(a)(4) of the Act (21 U.S.C. § 342(a)(4)), 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 through links in FDA's home page at www.fda.gov.
 
Your significant violations were as follows:
 
You do not have or have not implemented written verification procedures, product specifications and an affirmative step(s) for ensuring that fish you import are processed in compliance with the Seafood HACCP regulation, as required by 21 CFR Part 123.12(a)(2). 
 
Specifically,
a) You do not have written verification procedures and product specifications for any of the fishery products that you import from (b)(4) including but not limited to Maldive Fish Sambol, Wet Seeni Sambol, Katta Sambol, Seeni Sambol, Ambul Thiyal Fish, Bitter Gourd with Sprats, Dry Katta, Dry Seer, and Dry Tuna.
 
b) You do not have written verification procedures, product specifications, nor affirmative steps for any of the fishery products that you import from Sri Lanka from the manufacturer (b)(4) including but not limited to Maldive Fish Sambol, Katta Sambol, Red Coconut Sambol, Fried Sprats, Chili Fried Sprats,  Fried Dry Seer Fish, Dried Badun Fish and Fried Katta.
 
Examples of your imports from those processors are listed below:
 

Date
Entry Number
Product(s) include the following
Processor
11/25/12
(b)(4)
Dry Katta Fish, Dry Seer Fish, Bitter Gourd w/Sprats, Ambul Thiyal Fish
(b)(4)
09/10/12
(b)(4)
Maldive Fish Sambol, Katta Sambol, Seeni Sambol, Wet Seeni Sambol, Dry Tuna Fish
(b)(4)
11/25/12
(b)(4)
Katta Sambol, Red Coconut Sambol,
(b)(4)
04/11/11
(b)(4)
Katta Sambol, Fried Katta, Fried Dry Seer Fish, Fried Sprats.
(b)(4)
02/23/10
(b)(4)
Maldive Fish Sambol, Chili Fried Dry Seer Fish, Dried Badun Fish, Chili Fried Sprats
(b)(4)

 
During the inspection you provided a letter from (b)(4) dated 01/15/2013 stating that their production facility in (b)(4) is “governed by an HACCP Manual established nearly 10 years ago…”. The letter you obtained does not satisfy the requirement for affirmative steps [21 CFR Part 123.12(a)(2)(ii)]. In addition, you did not have any written verification procedures nor product specifications for the processors and fish/fishery products that you import, including those specifically identified above.
 
The above violations are not intended to be an all-inclusive list of violations in your plant. Other violations can subject your food products to legal action. It is your responsibility to ensure that all of your products are in compliance with all requirements of the Act and federal regulations.
 
We may take further action if you do not promptly correct these violations. For instance, we may take further action to refuse admission of your imported fish or fishery products under Section 801(a) of the Act (21 U.S.C. § 381(a)), including placing them on "detention without physical examination," seize your product(s) and/or enjoin your firm from further violating the Act.
 
Foods: Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees (21 U.S.C. 379j-31(a)(2)(B)). For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
 
We request that you notify this office in writing within 15 working days from your receipt of this letter of the current status of your corrective actions and the specific steps you have taken to correct the noted violations. In your response, include documentation of your corrective actions or steps towards long term, corrective actions. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and please include a timetable for the implementation of any remaining corrections.
 
Please send your reply to the Food and Drug Administration, Attention: 
 
Blake Bevill, Director
Compliance Branch
Los Angeles District
19701 Fairchild
Irvine, CA, 92612-2506
 
Refer to the Unique Identification Number (CMS Case: 394350) when replying. If you have questions regarding any issues in this letter, please contact David Whitman, Compliance Officer at 619-941-3769.
 
 
Sincerely,
/S/ 
Alonza E. Cruse, Director
Los Angeles District
 
 
cc:       
California Department of Public Health
Food and Drug Branch
Ingeborg Small, Branch Chief
1500 Capitol Avenue, MS-7602
P.O. box 997435
Sacramento, CA 95899-7435
Attn: FDA Correspondence