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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Fomar Import/Export Inc. 9/20/13

  

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

Public Health Service
Food and Drug Administration
 
Southwest Import District
4040 North Central XPY
Suite 300
Dallas, Texas 75204
Telephone:    (214) 253-5200
FAX:    (214) 253-5316 

 

WARNING LETTER
(2013-SWID-002)
 
September 20, 2013
 
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
 
 
Mr. Rodolfo Fonseca, Owner
Fomar Import/Export Inc.
220 S. Loara Street
Anaheim, CA 92802-1020
 
 
Dear Mr. Rodolfo Fonseca,
 
The Food and Drug Administration (FDA) conducted an inspection at your food facility warehouse, Fomar Import/Export Inc., located at 220 S. Loara Street, Anaheim, CA 92802 on August 28 through September 09, 2013. Our findings revealed and sample analyses confirmed the products held at the facility were adulterated within the meaning of Section 402(a)(3), [21 U.S.C. 342 (a)(3)] in that they were found to contain insect filth, and Section 402(a)(4), [21 U.S.C. 342 (a)(4)] because the products have been prepared, packed or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may been rendered injurious to health. You may find the Act and the regulations through links in the FDA’s Internet homepage at www.fda.gov.
 
At the conclusion of the inspection, our investigator provided you with a Form FDA-483, which delineated a number of gross insanitary conditions present in your warehouse at the time of the inspection. The following is a list of some of insanitary conditions observed during the inspection:
 
1)    Live and dead insects too numerous to count, including insect larva and frass were observed in, on, and near foods stored throughout your facility and warehouse. At least 4 rodent pellets were observed along the northeast and west-center sides of the warehouse. The roll-up door was keep open to the outside at all times during the inspection and there were gaps large enough to allow ingress of pests, particularly a 3 inch door gap and a 1 inch roll-up door gap on the northwest side of the warehouse, and 4 or more half-inch wide gaps along the roll-up door and adjacent door on the southeast side of the warehouse.
2)    There were loose dried chili peppers and tamarind pods on the floors, under the rafters and throughout the warehouse, including open cartons and bags of food products on the ground. Dirt, dust, and cob webs with live spiders in them were observed in rafters and corners throughout all storage areas within the facility and warehouse.
3)    Two packing tables being used to repack food that were located on the northwest and south center sides of the warehouse were observed to have insects on them.
4)    Rubbish and debris was observed being stored in a (b)(4) non-working reefer container located inside the east warehouse, and piles of wood and trash, including a carton of dried chili on the ground were located outside to the east of the warehouse and under a (b)(4) container.
 
These findings demonstrate that you are not adequately cleaning or controlling pests in your facility.
 
This letter is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to ensure adherence to each requirement of the Act and regulations.
 
Your action to destroy some of the product being stored at your facility, with plans to fumigate other segregated product has been noted. However, we recommend that you take additional measures to prevent the introduction of pests, such as insects and rodents, into your facility, which may cause the food articles stored in your facility to be adulterated. Failure to promptly correct these deviations may results in regulatory actions, including seizure and/or injunction without further notice.
 
Please respond in writing within 15 working days of your receipt of this letter outlining the specific steps you have taken to bring your firm into compliance with the law. Your response should include each step taken to correct the violations and prevent their recurrence. If you cannot complete all corrections within 15 working days, we expect you to explain the reason for the delay and state when any remaining deviations will be corrected.
 
Please send your reply to U.S. Food and Drug Administration, Attention: Joseph Brady, Compliance Officer, at the following address: 2320 Paseo de las Americas, Suite 200, San Diego, CA 92154. If you have questions regarding the issues in this letter, please contact Joseph Brady, CO at 619-941-3678 Ext. 3697.
                       
 
Sincerely,
/S/ 
Todd W. Cato
District Director