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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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California Delights, Inc.

  

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

Public Health Service
Food and Drug Administration
 
San Francisco District
Pacific Region
1431 Harbor Bay Parkway
Alameda, CA 94502-7070
Telephone:    510-337-6700
        FAX:    510-337-6701

 

 
WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Zaber A. Shahbaz, President/Owner;
California Delights, Inc.
1528 Main Street, Suite C
Newman, CA 95360-1344

Dear Mr. Shahbaz:

The Food and Drug Administration (FDA) conducted an inspection of your facility, located at 1528 Main Street, Suite C, Newman, California, from August 3 through 25, 2010. The inspection revealed significant violations of FDA’s  Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food (CGMP) regulation under Title 21, Code of Federal Regulations, Part 110  (21 CFR 110). At the close of the inspection, on August 25, 2010, you were issued a form FDA 483, List of Inspectional Observations, which included a number of insanitary conditions at your manufacturing facility. These conditions cause the foods stored and processed 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)] in that they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or may have become injurious to health. You can find links to the Act and regulations at FDA's website at www.fda.gov.
 
We acknowledge that on August 11, 2010 you voluntarily destroyed, under FDA supervision, (b)(4) lbs. of products stored in the Dry Storage Warehouse which were infested with insects. On August 23, 2010 you further voluntarily destroyed, under FDA supervision, approximately (b)(4) lbs. of products stored in the Dry Storage Warehouse that were infested with insects.
 
Specifically, the inspection revealed the following violations:
  1. No pests shall be allowed in any area of a food plant, and effective measures shall be taken to exclude pests from the processing areas and to protect against the contamination of food on the premises by pests, as required by 21 CFR 110.35(c). However, your firm failed to exclude pests from the processing areas of your food plant and to protect against the contamination of food on the premises as evidenced by:
The following, on 08/04/2010 and 08/06/2010, in your Dry Storage Warehouse:
  • Various insects, too numerous to count, both live and dead, including larvae, located on a pallet of (b)(4) lbs. bags of oats. Throughout the pallet, in every layer and on every bag, were insects. Randomly selected bags on this pallet contained both live and dead insects, including larvae, inside and outside each bag of oats.
  • More than 25 live and dead insects were located on a pallet of (b)(4) lbs. bags of cocoa powder. Live and dead insects were on the exterior of the bags.
  • More than 25 live and dead insects were on a pallet of (b)(4) lbs. boxes of chocolate-covered almonds with raspberry flavoring. Randomly selected boxes from this pallet exhibited live and dead insects inside and outside the boxes.
  • Various insects, too numerous to count, were on at least (b)(4) pallets of product samples and other raw materials. Throughout each of the pallets, on every layer, and in every case that was opened, were insects, both live and dead. 
On 08/03/2010:
  • At least 5 insects were flying around and landing on a sorting conveyor located opposite the metal racks of palletized product in the Dry Storage Warehouse where employees were sorting pistachios. The roll up door to the exterior of the building at the west wall was wide-open during sorting operations.
The following, on 08/04/2010, in your Main Kitchen:
  • More than 100 live and dead insects were inside three ceiling light fixtures located above the roaster and processing tables while seasoned nuts were being processed.
The following, on 08/18/2010 and 08/19/2010, in your Cold Storage Room:
  • Various insects, too numerous to count, both live and dead, along with larvae, located on a pallet of (b)(4) lbs. boxes of walnuts. Throughout the pallet, on every layer, and on every box, were insects. Both live and dead insects, including larvae, were inside three randomly selected boxes that were opened and examined. Live and dead insects and larvae, too numerous to count, insect webbing, and what appeared to be insect eggs were on the walnuts.
  • Live and dead insects, too numerous to count, were on (b)(4) pallets of (b)(4) lbs. boxes of banana chips. While collecting samples from randomly selected boxes from the four pallets, live and dead insects were inside each box of banana chips sampled.
  • Live and dead insects and larvae, too numerous to count, were on boxes and on product, of Mexican Chili Mango.
  • More than 3 larvae were located on (b)(4) pallets of (b)(4) lbs. boxes of Yogurt Flavored Confectionery Ribbons.
Laboratory analysis of your products and product packaging, including, but not limited to, your raw almonds, cocoa powder, Mexican Chili mango, and banana chips, identified multiple species of insects including Merchant Grain Beetle adults and larvae, Indian Meal Moth adults and larvae, Red Flour Beetles, a Dried Fruit Beetle, and insect excreta. These insect pests are stored product pests which are associated with the improper storage and handling of foods.
  1. The grounds about a food plant shall be kept in a condition that will protect against the contamination of food, including properly storing equipment, removing litter and waste, and cutting grass or weeds within the immediate vicinity of the plant buildings or structures that may constitute an attractant, breeding place, or harborage for pests, as required by 21 CFR 110.20(a)(1). However, from 8/6/10 through 8/23/10, your firm failed to properly store equipment and remove litter and waste within the immediate vicinity of the plant buildings or structures as exhibited by unused equipment, as evidenced by:
  • A pile of returned product, and pallets of packaging outside, comingling in an area outside the firm’s Dry Storage Warehouse and Cold Storage Room.
  • Unused equipment was haphazardly stored outside the perimeter of the processing facility. More than 10 flying insects were in the vicinity of the unused equipment located near the opened roll-up doors, which leads to the firm's Dry Storage Warehouse and Cold Storage Room.
  1. The plant and facilities shall be constructed in such a manner that floors, walls, and ceilings may be adequately cleaned and kept in good repair and that aisles or working spaces are provided between equipment and walls and are adequately unobstructed and of adequate width to permit employees to perform their duties and to protect against contaminating food or food contact surfaces with clothing or personal contact, as required by  with 21 CFR 110.20(b)(4). However, your firm failed to keep the plant in good repair and maintain aisles or working spaces between equipment and walls unobstructed and of adequate width for employees to perform their duties as evidenced by:
On 8/06/10:
    • Pallets of food products were stored directly against the storage rack facing the south wall in the Dry Storage Warehouse, preventing employees from cleaning behind the pallets.
On 8/18/10:
    • Pallets of food products were stored directly against the storage rack facing the north wall in the Cold Storage Room, preventing employees from cleaning behind the pallets.
4. Cleaning and sanitizing of utensils and equipment shall be conducted in a manner that protects against contamination of food, food contact surfaces, or food-packaging materials, in order to comply with 21 CFR 110.35(a). However your firm failed to properly clean and sanitize utensils and equipment in a manner to protect against the contamination of food, as evidenced by:  
 
On 08/03/2010:
  • A two compartment sink located inside the employee restroom at the Chocolate Gallery is also used for cleaning utensils from the Chocolate Gallery. The drain board of the two compartment sink is adjacent to and within 6 inches of the toilet, with no partition between the sink and the toilet.
On 8/04/10:
  • Equipment in the Chocolate Gallery exhibited an accumulation of food debris, dust and dirt. Specifically:
o  Dried chocolate and food debris were present inside and outside all cool air accordion ducts utilized for cooling chocolate inside the mixers.
o  Levers used to turn mixers on and off had covered in layers of dirt, dust, and food debris.
o  The grooves of the white handles on a red cart used to transport product had an accumulation of dark brown debris.
 
This letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with the Act and with the regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, Form FDA 483, issued at the closeout of the inspection are symptomatic of serious sanitation problems in your firm's facility. You should investigate and determine the causes of these violations and take prompt action to correct the violations.
 
Failure to implement corrective action may result in regulatory action initiated by the FDA without further notice. Such action may include seizing your products and/or enjoining your firm from operating.
 
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the current status of your corrective actions and the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again.  Your response should include documentation on how you plan to protect your food products from possible contamination and/or any other useful information that would assist us in evaluating your corrections. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. 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 written response should be sent to:
 
Warren E. Savary
U.S. Food and Drug Administration
San Francisco District Office
1431 Harbor Bay Parkway
Alameda, CA 94502

If you have any questions about the content of this letter please contact Warren E. Savary, Compliance Officer, at 510-337-6821.

Sincerely,
/S/
Barbara J. Cassens
San Francisco District Director