Inspections, Compliance, Enforcement, and Criminal Investigations
Sunrise Donuts, LLC 8/9/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
300 River Place
Detroit, MI 48207
FAX : 313-393-8139
August 9, 2013
Mr. Manilal J. Chandhari, Manager
Sunrise Donuts, LLC
1905 North Wayne Street
Angola, IN 46703-9101
Dear Mr. Chandhari:
The Food and Drug Administration (FDA) inspected your food processing facility located in Angola, Indiana from June 13, 2013 through June 27, 2013. The FDA investigator found significant violations of FDA’s Current Good Manufacturing Practice (CGMP) regulations in manufacturing, packing or holding human food, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110). These violations cause the foods manufactured at your facility to be adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. §342(a)(4)] in that they were prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth or rendered injurious to health. You can find the FD&C Act and its implementing regulations on FDA’s home page at www.fda.gov.
The investigator’s observations were presented to you on an FDA-483, Inspectional Observations, at the conclusion of the inspection on June 27, 2013. We have not received a written response to the inspectional observations.
The significant violations documented during the inspection include the following.
1. Failure to maintain equipment, utensils and finished food containers in an acceptable condition through appropriate cleaning and sanitizing, as necessary, as required by 21 CFR 110.80(b)(1).
a. On June 13, 2013 and June 14, 2013, scrapers and spatulas used to make donuts were stored in brown liquid that appeared to be soiled water. The liquid in the bucket was used to clean product residue off the scrapers and spatulas before and after use. The scrapers were used to scrape donut fillings from plastic buckets into a hopper that fills ready to eat donuts. The spatulas were used for icing donuts.
b. On June 13, 2013 and June 14, 2013, the investigator observed metal spatulas in a bucket of water that appeared to contain a mold like substance on the surface of the water and throughout the bucket. The metal spatulas in the bucket were used to ice donuts.
c. On June 13, 2013, June 14, 2013 and June 26, 2013, the investigator observed large dry pieces of yellow product residue on and in mixing bowls, and adhering to mixing paddles during the manufacture of donut dough.
2. Failure to handle and maintain equipment, containers, and utensils used to hold food in a manner that protects against contamination, as required by 21 CFR 110.80(b)(7). On June 13, 2013 and June 14, 2013, plastic bins used for mixing raw ingredients and mixing vat paddles were stored on a soiled floor.
3. Failure to handle work-in process in a manner that protects against contamination, as required by 21 CFR 110.80(b)(5). On June 13, 2013 and June 14, 2013, the investigator observed two bags of yeast inside a mixing bowl containing a batch of donut dough already in process. The exterior of the yeast bags were in direct contact with dry ingredients.
4. Failure to take effective measures to exclude pests from the processing areas, as required by 21 CFR 110.35(c).
a. On June 13, 2013, the shipping and receiving door remained open to the outside during the production of ready to eat donuts. The open door led directly into the production and processing areas.
b. On June 13, 2013 and June 14, 2013, large and small flying insects were observed on food contact surfaces including the mixers, cooling racks, utensils and production tables during the production of ready to eat donuts. Flying insects were also observed on finished donuts.
5. Failure to store and hold raw materials in a manner that protects against contamination, as required by 21 CFR 110.80(a)(7). On June 13, 2013 and June 14, 2013, the investigator observed open and uncovered bags and containers of raw materials such as flour, corn starch, sugar, and donut toppings. For example an open bag of cake donut mix was stored directly on the soiled floor next to the mixing vat closest to the shipping and receiving doors. The shipping doors were left open during operation on June 13, 2013. Additionally, sugared donut toppings were stored in uncovered tiered plastic trays. The trays were stored under a table adjacent to an open door leading into the retail store.
6. Failure to provide effective hand-cleaning and sanitizing preparations, as required by 21 CFR 110.37(e). On June 13, 2013 and June 14, 2013, soap dispensers near hand washing sinks in the processing area did not contain soap.
7. Failure to ensure that manufacturing operations including filling, assembling, packaging, and other operations are performed in a manner to protect food from contamination, as required by 21 CFR 110.80 (b)(13) (v). On June 13, 2013, the investigator observed an employee’s gloved hand touch the soiled floor while picking up a tray and donuts. The employee resumed handling ready to eat donuts without washing their hands or replacing their gloves.
8. The design, materials and workmanship of equipment and utensils fail to allow adequate cleaning and maintenance, as required by 21 CFR 110.40(a). On June 13, 2013, the investigator observed that a wooden brush used to clean a food contact surface was splintering and constructed of a porous material.
9. Failure to maintain buildings, fixtures, and other physical facilities of the plant in a sanitary condition and keep them in repair sufficient to prevent food from becoming adulterated, as required by 21 CFR 110.35(a). The investigator observed product build up on a wall directly above a stainless steel table utilized to process donuts. The product build up was peeling directly onto the stainless steel table where donuts were being filled and glazed.
10. Failure to wear hair restraints as required by 21 CFR 110.10(b)(6). On June 14, 2013, two production workers failed to wear hair restraints while handling in-process donuts within the donut assembly area.
11. Failure to dispose of rubbish in a manner that minimizes the potential for waste becoming an attractant and harborage or breeding place for pests, as required by 21 CFR 110.37(f).
a. The investigator observed trash plied up on the floor in multiple locations in processing area.
b. Product waste was observed on the floor under a mixing vat and on the processing room floor.
This letter may not list all the violations at your facility. You are responsible for ensuring that all of your products are in compliance with the applicable statutes and regulations administered by FDA. You should take prompt action to correct these violations. Failure to promptly correct these violations may result in regulatory action by FDA without further notice. Such action includes seizure of your products or injunction.
We request that you notify this office in writing, within 15 working days of receipt of this letter. Your response should include the specific steps you have taken to correct the violations. If you cannot complete all of the corrections within 15 working days, state the reason for the delay and the time within which corrections will be completed.
Section 743 of the Act (21 U.S.C. § 379j-31) authorizes FDA to assess and collect fees to cover costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees [21 U.S.C. § 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
Your response should be directed to: Cicely Vaughn, Compliance Officer, U.S. Food and Drug Administration, Detroit District Office 300 River Place, Suite 5900, Detroit, MI 48207-4291. If you have any questions, please call Compliance Officer Vaughn at (313) 393-8297 or an email to her at Cicely.Vaughn@fda.hhs.gov.
Glenn T. Bass
Detroit District Office
cc: Mr. Manilal J. Chandhari, Manager
Sunrise Donuts, LLC
P.O. Box 466
Auburn, IN 46706