| Public Health Service Food and Drug Administration |
Los Angeles District 19701 Fairchild Irvine, California 92612-2506 Telephone (949) 608-2900 Fax (949) 608-4415 |
Department of Health and Human ServicesWARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
April 18, 2011
W/L 31-11
Mr. Oscar Lopez Villalobos, Co-Owner and President
Bonaterra Products, Inc.
6015 District Blvd.
Maywood, CA 90270-3560
Dear Mr. Lopez Villalobos:
The Food and Drug Administration (FDA) conducted an inspection of your food storage facility, located at 6015 District Blvd., Maywood, CA, from January 4 – 14, 2011. During the inspection, FDA investigators documented serious violations of FDA’s Current Good Manufacturing Practice regulations for manufacturing, packing, or holding human food, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110). These conditions cause the spices and chilies stored at your facility to be 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)] because these food products have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. You can find the Act and its associated regulations on the Internet through links on the FDA web page at www.fda.gov.
The following significant violations were observed during the inspection:
1) You failed to take effective measures to exclude pests from the processing areas of your facility and to protect against the contamination of food on the premises by pests, as required by 21 CFR 110.35(c).
The conditions observed include the following:
• On 1/12/11, a live rodent ran across the floor in the northeast area of the warehouse.
• Rodent excreta pellets on bags and on closed and exposed boxes of spices and chilies.
• Rodent excreta pellets on pallets and shelving storing spices and chilies.
• Dead insect particles too numerous to count on more than 100 bags of food product such as spices and chilies.
You have not provided any documentation of specific steps taken to exclude pests from your facility and to protect against the contamination of food on the premises by pests.
2) You failed to maintain buildings, fixtures, and other physical facilities in sanitary condition and failed to keep them in repair sufficient to prevent food from becoming adulterated, as required by 21 CFR 110.35(a).
The conditions observed include the following:
• Food products, such as powdered and whole spices were located on the floor throughout the warehouse.
• Food debris and rodent excreta pellets were located throughout the warehouse on the floor, pallets, and shelving.
• Over ten wet boxes of Chile Guajillo due to apparent roof leaks. FDA lab analysis of samples taken of Chile Guajillo stored at your facility indicated this food product to be contaminated with mold.
• Five of the six glass windows in the warehouse ceiling were broken and cracked.
• A hole approximately 1' x 2' in the northeast ceiling of the restroom and mold-like substance in this area.
You have not provided any documentation of specific steps taken to correct the above referenced conditions.
3) You failed to provide, where necessary, adequate screening or other protection against pests, as required by 21 CFR 110.20(b)(7).
The conditions observed include the following:
• A window in the restroom was propped open with a wadded up paper towel and was inadequately screened to prevent the entry of pests.
• A hole approximately 1" x 2" in the middle roll-up door about 4” from the bottom serving as an entryway for pests.
• A gap approximately under the southernmost roll-up door in the east wall serving as an entryway for pests.
• A hole approximately 6" long and 2-3" high in the lower corner of the rear man door serving as an entryway for pests.
• Gaps greater than 1" along the north wall juncture at the restroom wall, and between two wood panels on the north wall serving as an entryway for pests.
We acknowledge that, on 1/12/11, the FDA investigators observed that 3 window panes on the west window had been replaced. You stated that all of the damaged ceiling glass panes would be replaced within one week. However, you have not provided any documentation of this repair, or of specific steps taken to correct the above referenced conditions.
4) You failed to provide sufficient space for storage of materials as necessary for the maintenance of sanitary operations and the production of safe food, as required by 21 CFR 110.20(b)(1).
The conditions observed include the following:
• Food products, utensils and equipment were lined up two and three pallets deep in front of walls and in the middle of aisles.
• Twenty or more boxes of corn husks were observed to be stacked at least 5 feet high and against walls with no space between them.
• The areas along the perimeter of the warehouse were inaccessible due to the placement of food items and boxes.
You have not provided any documentation of specific steps taken to correct the above referenced conditions.
The above items are not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure that your facility and food products comply with the applicable laws and regulations administered by FDA. You should take prompt action to correct these violations. Failure to do so may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure and/or injunction.
We acknowledge that from February 4 through February 8, 2011, your firm voluntarily destroyed all food products on your premises, including the moldy Chile Guajillo, that were not packaged in hermetically sealed containers, which were embargoed on January 6, 2011 by the California Food and Drug Branch, California Department of Public Health.
Please notify this office in writing within 15 working days of receipt of this letter, of the specific steps you have taken to correct the noted violations and to prevent recurrence. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Your response should be sent to:
Mr. Blake Bevill
Director, Compliance Branch
Food and Drug Administration
19701 Fairchild
Irvine, CA 92612-2506
If you have any questions about the content of this letter please contact: Dr. William Vitale, Compliance
Officer at 949-608-2919.
Sincerely yours,
/S/
Alonza E. Cruse
District Director
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