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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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International Desserts and Delicacies

   

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


CERTIFIED MAIL
RETURN RECEIPT REQUESTED


June 16, 2009

 

W/L 20-09


Robbie T. Jacobs, President
International Desserts and Delicacies
743 Milford Street
Glendale, CA 91203-1570


Dear Mr. Jacobs:

The Food and Drug Administration (FDA) inspected your bakery product processing facility, located at 743 Milford Street, Glendale, California 91203 on March 9-25, 2009. The inspection included the collection of environmental samples (via sponge swabs) at various locations within your processing facility to be analyzed for the presence of Salmonella spp. FDA laboratory analysis confirmed Salmonella bacteria in one subsample collected from the processing room and this finding leads FDA to conclude that your firm's bakery products have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health (Section 402(a)(4) [21 U.S.C. § 342(a)(4)] of the Federal Food, Drug, and Cosmetic Act (the Act)).


The inspection also revealed that you have serious violations of the Current Good Manufacturing Practice (CGMP) regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 110). Failure to manufacture foods in accordance with the requirements of 21 CFR 110, renders your film's bakery products adulterated within the meaning of Section 402(a)(4) of the Act, 21 U.S.C. § 342(a)(4). You may find the Act and the Current Good Manufacturing Practice regulations for Foods through links in FDA's home page at www.fda.gov.


Environmental samples were collected throughout your processing facility on March 9 and 10, 2009. Subsample number 73 from FDA Sample number 377660 collected on March 9, 2009, from the surface of a wheel on a processing rack used to hold trays of unpackaged baked cookies in the production room was found positive for Salmonella blockely. Finding Salmonella very near to where food is exposed indicates a high risk for product contamination. This finding also indicates that Salmonella may have been become established in a niche environment in your facility.


Appropriate control of Salmonella in a food processing environment requires expert knowledge of the unique characteristics of the organism. Although we acknowledge that your firm plans to include finished product testing in your quality assurance plan, increased finish product testing is not sufficient to control the risk of Salmonella in critical environments of your facility. It is essential to identify the areas of the food processing plant where this organism is able to grow and survive (niche areas) and to take such corrective actions as necessary to eradicate the organism by rendering these areas unable to support the growth and survival of the organism.


At the conclusion of the inspection, you were issued a Form FDA-483 (copy enclosed), which delineated a number of significant deficiencies, including the following:


1. All persons working in direct contact with food, food-contact surfaces, and food-packaging materials must wear suitable outer garments during processing of foods that protect against contamination of food and food contact surfaces, to comply with 21 CFR 110.10(b)(1).
However, the following deficiencies were observed:


A) On 3/9/09, 3/10/09, and 3/17/09, a production employee's bare arms were observed coming into direct contact with cookie dough at the (b)(4) mixer.


B) On 3/17/09, cookie dough was observed on the rolled up sleeves of the smock worn by the production employee at the (b)(4) mixer. The production employee's soiled smock was not replaced between product changes (e.g., from Oatmeal Raisin to Trail Mix to Peanut Butter Chocolate Chip).


C) On 3/10/09, a production employee was observed entering and exiting an employee restroom wearing a smock and hair net and resuming work in the finished product packaging area without changing the smock or hair net.


D) On 3/17/09, production employees were observed wearing their smocks and hair nets in the parking lot and upon returning to work in the production room, they did not change their smocks or hair nets.


2. All persons working in direct contact with food, food-contact surfaces, and food-packaging materials must wash and sanitize hands thoroughly in an adequate hand-washing facility before starting work and after each absence from a work station to comply with 21 CFR 110.10(b)(3). However, the following deficiencies were observed:


A) On 3/10/09, a production employee was observed entering the production room from the exterior door (located adjacent to the cargo door) and resuming work in the finished product packaging area without washing her hands. A hand wash sink is available for employee use in the production room.


B) On 3/17/09, two production employees returning to the production room from the exterior premises did not wash their hands prior to resuming work in the finished product packaging area and (b)(4) machine. A hand wash sink is available for employee use in the production room.


3. You must conduct cleaning and sanitizing operations at your plant 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, we observed the following on 3/17/09:


A) A production employee did not properly wash the white plastic cylinder equipment part prior to re-use in the (b)(4) machine. The employee was observed rinsing the white plastic cylinder under running water prior to re-use in the (b)(4) machine.


B) On two occasions sanitizer level in the middle sanitizing compartment of the 3-compartment utensil wash sink was found to be too low; measuring at approximately 50 ppm. Production employees were observed sanitizing (b)(4) equipment parts in this sanitizing compartment prior to re-use.


C) Equipment parts (of the (b)(4) machine) were not submerged in the sanitizing compartment of the utensil wash sink for the appropriate time (2 minutes according to the hypochlorite sanitizer product label).


D) The metal bottom of the (b)(4) machine was observed with dark accumulation and grease-oil like material.


4. You must construct, handle and maintain equipment, containers and utensils used to convey, hold or store raw materials, work-in-progress, rework or food in a manner that protects against contamination during manufacturing, to comply with 21 CFR 110.80(b)(7). However, the following deficiencies were observed on 3/10/09 and 3/17/09:


A) Ingredient storage containers were not properly identified to prevent cross contamination between allergen and non-allergen products. Numerous plastic (b)(4) drum containers were not properly identified in the mixing area of the production room and in the warehouse.


B) Numerous plastic "(b)(4)" drum food storage containers were observed with deep tears and cuts resulting in an accumulation of debris in these cracks/crevices.


5. All persons working in direct contact with food, food-contact surfaces, and food-packaging materials must wear effective hair restraints while processing food when appropriate, to comply with 21 CFR 110.10(b)(6). However, on 3/9/09, 3/10/09, and 3/17/09, two production employees with facial hair were observed not wearing beard covers while handling food in the production room.


6. Your processing facility must be constructed in such a manner as to allow walls and ceilings to be kept in good repair, to comply with 21 CFR 110.20(b)(4). However, the following deficiencies were observed in your facility:


A) On 3/17/09, dark dust-like accumulation was observed on the ceiling of the walk-in freezer. Open racks of cookies are cooled in this walk-in freezer.


B) On 3/9/09, 3/10/09, and 3/17/09, peeling paint was observed on the ceiling directly above the bulk food storage area in the production room (by the mixing area).


C) On 3/9/09, 3/10/09, and 3/17/09, damaged ceiling panels (with exposed insulation materials) were observed in the warehouse directly above food storage.


7. You must provide hand washing facilities that are adequate and convenient, including sanitary towel service or adequate hand-drying devices, to comply with 21 CFR 110.37(e)(3).

However, we observed on 3/9/09 and 3/17/09 that the hand towel dispenser in the women's employee restroom was empty and no other means of drying employee hands was provided.


8. You must confine employees who are eating food, chewing gum, drinking beverages or using tobacco to areas other than where food is exposed or where equipment or utensils are washed, to comply with 21 CFR 110.10(b)(8). However, the following deficiencies were observed in your facility:


A) On 3/9/09, two production employees in the finished product packaging area were observed chewing gum.


B) On 3/17/09, a production employee handling empty cookie trays was observed chewing gum.


9. You must properly identify toxic sanitizing agents in a manner that protects against contamination of food, food-contact surfaces, or food-packaging material to comply with 21 CFR 110.35(b)(2). However, on 3/10/09 an unidentified spray bottle with a clear liquid was observed hanging from the (b)(4) machine.


We have reviewed your firm's written response dated March 26, 2009. This response, if properly implemented, appears adequate to correct the CGMP conditions numbered 1-9 above; however, FDA will evaluate and verify these corrections during the next inspection.


The above violations are not meant to be an all-inclusive list of deficiencies in your facility. It is your responsibility to ensure that all of your products are in compliance with applicable laws and regulations. You should take prompt action to correct all of the violations noted in this letter. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction.


Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these deviations. If you cannot complete all corrections before you respond, please explain the reason for your delay and state when you will correct any remaining deviations.


If you have any questions relating to this letter you should contact Robert B. McNab, Compliance Officer, at (949) 608-4409. Your written reply should be addressed to:


Director, Compliance Branch
U.S. Food and Drug Administration
19701 Fairchild Rd.
Irvine, California 92612


Sincerely

/S/

Alonza E. Cruse, Director
Los Angeles District
cc: Jeffrey Jacobs, Treasurer
International Desserts and Delicacies
743 Milford Street
Glendale, CA 91203-1570


cc: Jeff Farrar, DVM, PhD, MPH
Branch Chief
Food and Drug Branch
California Department of Public Health
1500 Capitol Avenue-MS 7602
P.O. Box 997413
Sacramento, CA 95899-7413


Enclosure