Inspections, Compliance, Enforcement, and Criminal Investigations
California Delights, Inc.
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94502-7070
RETURN RECEIPT REQUESTED
Zaber A. Shahbaz, President/Owner;
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.
- 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:
- 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.
- 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.
- 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.
- 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.
- 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.
- 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:
- 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.
- 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.
- 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.
- Equipment in the Chocolate Gallery exhibited an accumulation of food debris, dust and dirt. Specifically:
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.
Barbara J. Cassens
San Francisco District Director