Inspections, Compliance, Enforcement, and Criminal Investigations
Wendell Corporation dba Regalo Bakery 8/29/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
San Francisco District
VIA UNITED PARCEL SERVICE
August 29, 2012
Ruby B. Ho, President
421 North King Street
Honolulu, Hawaii 96817
Dear Ms. Ho:
The Food and Drug Administration (FDA) conducted an inspection of your bakery located at 421 North King Street, Honolulu, Hawaii, between June 19 and June 21, 2012. 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 www.fda.gov.
Your significant violations are as follows:
1. As required by 21 CFR 110.35(c), effective measures must be taken to exclude pests from the processing areas and protect against the contamination of food on the premises by pests. However, our investigator observed the following during the inspection:
• Three flies were seen landing on the wooden baker's table and the edge of the large mixing bowl while pastries were being processed.
• Approximately ten flies were seen in the pastry processing area. Two flies were observed landing on in-process pastry dough in the small mixer.
• A fly was observed landing on the wooden baker’s table while bread dough was being processed.
We acknowledge that your employee disposed of the pastry dough and cleaned the mixer during the inspection in response to the observations.
2. As required by 21 CFR 110.20(b)(7), you must provide where necessary adequate screening or other protection against pests. However, during our inspection, our investigator observed the back door in the bread making room and the pastry processing room was left open when not in use.
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. In addition, they must conform to hygienic practices while on duty to the extent necessary to protect against contamination of food. This includes confining beverages and food consumption to areas other than where food may be exposed, as required by 21 CFR 110.10(b)(5). However, our investigator observed the following during our inspection:
• An employee arrived to work, wiped their nose, coughed into both hands then used their bare hands to handle bread dough without washing hands throughout this process.
• Employees were seen eating food and drinking beverages throughout the production areas while food was being processed.
4. As required by 21 CFR 110.40(a), equipment and utensils shall be so designed as to be adequately cleanable, and shall be properly maintained. Additionally, per 21 CFR 110.40(c), equipment that is in the food handling area that does not come into contact with food shall be so constructed that it can be kept in a clean condition. However, our investigator observed the following during our inspection:
• Equipment being used to process bread and pastry dough is heavily worn and not easily cleanable, including the wood baker's tables, and the intake surface and fabric belt used to convey dough on the dough sheeting machine.
• The bread slicing machine in the bread making room is partially constructed with worn wood, which baked bread was observed contacting.
• The baking sheets used to cool bread were lined with cardboard directly beneath a sheet of baking paper. The cardboard had build-up of residue and is not easily cleanable.
• The table supporting the small mixer in the pastry processing room is worn, has build-up of old food debris, and is not easily cleanable.
5. As required by 21 CFR 110.35(b)(1), 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 investigator observed the following during the inspection:
• Equipment and utensils are not sanitized after being washed and rinsed.
• Ready to use utensils in the pastry room are stored with build up of old food residue.
• The interior and exterior of ingredient storage bins in the pastry room have built up food residue.
6. As required by 21 CFR 110.80(b)(2), all food manufacturing, including packaging and storage, shall be conducted under such conditions and controls as are necessary to minimize the potential for the growth of microorganisms, or for the contamination of food. Additionally, per 21CFR 110.40(e), you must provide an accurate indicating thermometer, temperature measuring device, or temperature recording device in each freezer and cold storage compartment used to store food capable of supporting the growth of microorganisms. However, our investigator observed the following during the inspection:
• The internal temperature taken by our investigator of both raw shell eggs and liquid eggs being stored in a reach-in cooler in the bread making room measured over 51°F at the beginning and end of a four hour span.
• A package of shredded cheese labeled “KEEP REFRIGERATED” was found stored in a non-operational freezer. Our investigator measured the internal temperature of the packaged cheese and it read 73.4°F.
• There was no thermometer located in either the two-door cooler or operational freezer in the bread making room.
We acknowledge that you disposed of the eggs and shredded cheese during the inspection in response to the observations.
7. As required by 21 CFR 110.80(b)(9), you must dispose of adulterated food in a manner which protects against the contamination of other food. However, our investigator observed an employee dropping in-process dough onto the floor, picking it up, throwing it onto the wooden baking table, cutting it into two portions, then using each portion to wipe crumbs from the interior of empty bread pans before placing the dough into pans for baking.
8. As required by 21 CFR 110.37(e), you are required to provide hand-washing facilities that are adequate. However our investigator observed that there were no towels or hand drying device available at the hand washing sink in the toilet room. Also, hand washing signs are not posted at the hand washing sink in the bread making room or the toilet room.
9. As required by 21 CFR 110.35(a), you must maintain buildings, fixtures, and other physical facilities of the plant in a sanitary condition and kept in repair sufficient to prevent food from becoming adulterated. However, our investigator observed the underside of the freezer in the bread making room to be corroded and dripping water. Pooled water was seen on the floor beneath the freezer in the bread making room.
10. In order to comply with 21 CFR 110.35(b)(1), toxic materials which are not required to maintain clean and sanitary conditions, are unnecessary for use in laboratory testing procedures, are unnecessary for plant and equipment maintenance, and are unnecessary for use in plant operations must not be stored where food is processed or exposed. However, our investigator observed a can of latex paint, a bottle of multivitamins, and a bottle of cough suppressant stored above packaging materials in the bread making room.
11. Your plant and facilities must be constructed in such a way to facilitate maintenance and sanitary operations for food-manufacturing purposes to meet the requirements of 21 CFR 110.20(b). Specifically, you must provide sufficient space for storage of materials as necessary for the maintenance of sanitary operations and the production of safe food to comply with 21 CFR 110.20(b)(1). However, in the bread making room, our investigator observed the area to the left of the mixer cluttered with equipment such that the area is not easy to clean or observe potential pest activity.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.
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:
Lawton W. Lum
Director of Compliance
1431 Harbor Bay Parkway
Alameda, California 94052
Refer to the Unique Identification Number (CMS case 347700) when replying.
If you have any questions about the content of this letter please contact Ms. Aleta T. Flores, Compliance Officer at (510) 337-6821.
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.
Barbara J. Cassens