| Public Health Service Food and Drug Administration |
San Francisco District |
Department of Health and Human Services
WARNING LETTER
VIA UPS
December 14, 2011
Carl M. Skropeta, President
The Cake Box, Inc.
3527 Wilkinson Lane
Lafayette, California 94549
Dear Mr. Skropeta:
The Food and Drug Administration (FDA) conducted an inspection of your bakery located at 3527 Wilkinson Lane, Lafayette, California on September 20 28, 2011. During our inspection, FDA investigators documented serious violations of the Current Good Manufacturing Practice (CGMP) regulation for foods, Title 21, Code of Federal Regulations (CFR), Part 110 (21 CFR 110). These violations cause the food products produced in your facility to be adulterated within the meaning of Section 402(a)(4) [21 U.S.C. § 342(a)(4)] of the Federal Food, Drug, and Cosmetic Act (the Act), in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health. You can find the Act and the FDA regulations through links in FDA's homepage at Your significant violations are as follows:
1. As required by 21 CFR 110.35(c), you must not allow pests in any area of a food plant. Effective measures must be taken to exclude pests from the processing areas and to protect against the contamination of food on the premises by pests. However, our investigators observed the following evidence of a lack of pest control:
• A dead rat was found located 3 feet from the storage of raw ingredients.
• Twenty five to thirty rodent pellets were found in the firm's storage room, 1 foot from the storage of raw ingredients.
• Five to 6 moths were seen in the production room. Four of the six were resting on a cotton cloth used to cover raw bread dough. One of the six moth was seen resting on the wooden table, in use to form bread dough.
• Rodent pellets were located in the storage room, as close as five feet from the storage of finished product cooling racks.
• Rodent nesting material located within the storage room.
2. As required by 21 CFR 110.80(b)(1), you must maintain all equipment, utensils, and finished food containers in an acceptable condition through appropriate cleaning and sanitizing, as necessary. In addition, as required by 21 CFR 110.35(d), you must clean all food-contact surfaces, including utensils and food-contact surfaces of equipment, as frequently as necessary to protect against the contamination of food. However, our investigators observed the following during the inspection:
• Roller racks used to transport raw bread dough and cooked/finished buns were covered with old product residue.
• Several baking pans were noted to have an accumulation of old product residue.
• Cotton cloths, used to cover raw bread dough, were covered with old product buildup.
• An employee was seen using a dough scraper to scrap the remnants of a dead moth off the table.
3. As required by 21 CFR 110.10(b)(3), all persons working in direct contact with food, food-contact surfaces, and food-packaging materials must wash hands thoroughly (and sanitize if necessary to protect against contamination with undesirable organisms) in an adequate hand-washing facility at any time when the hands may have become soiled or contaminated.
However, our investigators observed the following during the inspection:
• Employees were observed starting work without washing their hands. These employees were seen handling the raw bread dough with their bare hands.
• An employee was seen smashing a moth on the production table with his bare hands, used the same hand to wipe it onto the floor, and immediately returned to forming bread dough without washing his hands.
4. As required by 21 CFR 110.10(a), any person who is shown to have, or appears to have an illness, open lesion, including boils, sores, or infected wound, or any other abnormal source of microbial contamination by which there is a reasonable possibility of food, food-contact surfaces, or food packaging materials becoming contaminated, shall be excluded from any operation which may be expected to result in such contamination until the condition is corrected. However, our investigators observed an employee with an open lesion on the hand handling raw dough product without the use of hand coverings.
5. As required by 21 CFR 110.10(b), all persons working in direct contact with food, food-contact surfaces, and food-packaging materials must conform to hygienic practices while on duty to the extent necessary to protect against contamination of food. However, our investigators observed an employee was not wearing hair covering in the processing of finished, ready to eat muffins. Effective hair restraints such as hair nets or headbands must be worn where appropriate and in an effective manner (21 CFR 110.10(b)(6)).
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of 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. Include documentation of the corrective action you have taken. 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 directed to:
Darlene B. Almogela
Director of Compliance
1431 Harbor Bay Parkway
Alameda, California 94052
Refer to the Unique Identification Number (CMS case 238496) when replying.
If you have any questions about the content of this letter please contact Mr. Lawton W. Lum, Compliance Officer at (510) 337-6792.
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 applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, Form FDA 483 (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm's manufacturing systems. You should investigate and determine the causes of the violations and take prompt actions to correct the violations to bring your products into compliance. Failure to promptly correct these violations may result in legal action without further notice including seizure and injunction.
Sincerely,
/S/
Barbara J. Cassens
District Director
