Inspections, Compliance, Enforcement, and Criminal Investigations
American Yeast Corp. Tennessee 5/8/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|New Orleans District|
404 BNA Drive
Building 200 – Suite 500
Nashville, TN 37217
Telephone: (615) 366-7801
FAX: (615) 366-7802
May 8, 2012
WARNING LETTER NO. 2012-NOL-20
UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
Gary Edwards, President
American Yeast Corporation Tennessee
2405 North 2nd Street
Memphis, Tennessee 38127
Dear Mr. Edwards:
On January 9-12, 18, and 20, 2012, U.S. Food and Drug Administration (FDA) investigators inspected your fresh baker’s yeast manufacturing plant, located at 2405 North 2nd Street, Memphis, Tennessee. The inspection was conducted to determine your compliance with FDA’s Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 110). During the inspection, numerous insanitary conditions were documented, which could cause the food products manufactured by your facility to become adulterated. Accordingly, your food products are adulterated within the meaning of Section 402(a)(4) of the Food, Drug, and Cosmetic Act (the Act) [21 United States Code (USC) 342 (a)(4)] as they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or may have been rendered injurious to health. You may find the Act and associated regulations through links in FDA’s Internet home page at http://www.fda.gov.
We received Mr. Thomas W. Kolano’s (Plant Manager, American Yeast Corporation Tennessee) response, dated February 2, 2012, concerning our investigators’ observations noted on the FORM FDA 483 (FDA 483), Inspectional Observations, issued to him on January 20, 2012. Mr. Kolano’s responses are addressed below in relation to each of the noted violations. The significant violations include, but are not limited to, the following:
1. You failed to design and maintain the construction of your plant and facilities in such a manner as to ensure the floors may be adequately cleaned and kept clean and in good repair [21 CFR 110.20(b)(4)]. In addition, you failed to maintain your physical facility in a sanitary condition and in sufficient repair to prevent food from becoming contaminated [21 CFR 110.35(a)].
For example, on January 10 and 18, 2012, the mezzanine production area, where (b)(4) open rotating vacuum filters (RVFs) are located, was observed covered in standing water. Brown fluid was observed dripping from a valve from RVF No. (b)(4) onto the mezzanine floor. In-process yeast was observed near RVF No. (b)(4) and No. (b)(4) on the mezzanine floor. Finished yeast product manufacturing equipment, including extruders and packaging machines, is located directly under the mezzanine. The design of the edges of the mezzanine area does not prevent liquid from dripping from the mezzanine to the manufacturing equipment and floor directly below. Additionally, on January 10, 2012, during the dewatering process which occurs in the RVF area of the mezzanine, a fine liquid mist was observed in the air near the five pound production line where unwrapped finished yeast product (lot C57443T) was exiting an extruder on the manufacturing floor below the mezzanine.
Furthermore, holes and areas of flooring were observed absent approximately 20 inches to 10 feet from the five pound packaging line. The holes and missing areas of flooring were observed full of standing water. Numerous nicks, crevices, and small areas of missing flooring were observed throughout the packaging room where finished yeast product exits extruders on the two and five pound packaging lines.
We reviewed your firm’s response and conclude it is not adequate. Regarding the design of the facility, Mr. Kolano states you have commissioned an engineering study; however, no further information (such as, time frames or what you are doing in the meantime) is provided. Regarding the condition of the floor, Mr. Kolano states you will patch and seal the floors along with develop a “…maintenance prevention program….” This would be complete by March 31, 2012. This requires evaluation during a re-inspection of your facility.
2. You failed to ensure all personnel working in direct contact with food, food contact surfaces, and food packaging materials conform to hygienic practices while on duty to the extent necessary to protect against contamination of food [21 CFR 110.10(b)]. Specifically, you failed to maintain gloves, used in food handling, in an intact, clean, and sanitary condition [21 CFR 110.10(b)(5)]. For example, the following were observed on January 10, 2012, during production operations:
- An employee, working on the five pound packaging line, picked up, with his gloved hands, crumbled yeast product from the floor, threw the yeast in the trash, then immediately guided unwrapped, finished yeast product (lot C57443T) exiting the extruder without changing or cleaning his gloves.
- An employee, working on the five pound packaging line, adjusted a screen near the extruder, which was covered with debris, with his gloved hands, then immediately guided unwrapped, finished yeast product (lot C57443T) exiting the extruder without changing or cleaning his gloves.
We reviewed your firm’s response and concluded it is inadequate. Mr. Kolano states you “…will provide addition training to all packaging personnel as to the proper glove changing procedures when handling food and non-food items.” He further states this will be completed by February 17, 2012. Your firm’s response does not include training documentation, such as applicable sanitation procedures, training material, or employee training records. This requires evaluation during a re-inspection of your facility.
3. You failed to ensure all operations are conducted in accordance with adequate sanitation principles [21 CFR 110.80]. You failed to ensure all equipment, containers, and utensils are constructed, handled, and maintained during manufacturing or storage in a manner protecting against contamination [21 CFR 110.80(b)(7)]. Specifically, on September 8, 2011, you were notified of a complaint involving an approximately 1.5 inch piece of plastic found in your five-pound finished yeast product (lot CT53944T). Your firm’s investigation revealed the plastic as a portion of your conveyor belt located between the cutter and the wrapper on the five-pound packaging line. According to your CAPA 2011-33, your firm was aware the belt was in disrepair before the packaging of lot CT53944T on August 17, 2011. You continued to use the belt, which was in disrepair, as no replacement belt was available.
We reviewed your firm’s response and conclude it is inadequate. Mr. Kolano states, “The practice of packaging product on equipment in disrepair has been discontinued.” Your response does not include documentation of corrective action, such as equipment maintenance policies and procedures, nor does it address the status of finished product which was manufactured under such conditions yet was marketed and distributed. This requires evaluation during a re-inspection of your facility.
This letter is not intended to include a comprehensive list of deficiencies at your facility. It is your responsibility to ensure your facility operates in full compliance with the Act and the applicable federal regulations.
You should take prompt action to correct these violations, and you should establish procedures whereby such violations do not recur. Failure to correct these violations may result in regulatory action without further notice, including seizure or injunction.
You should notify this office in writing, within 15 working days from receipt of this letter, of the specific steps you have taken to correct the noted violations, including an explanation of each step taken to prevent recurrence. You should include in your response documentation, such as photographs, records, and other useful information, to assist us in evaluating your corrections. If corrective actions cannot be completed 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 USC 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 USC 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.
Please address your reply to Rebecca A. Asente, Compliance Officer, at the address above. If you have questions regarding the contents of this letter, please contact Ms. Asente at (504) 832-1290, extension 1104.
Patricia K. Schafer
New Orleans District
cc: Thomas W. Kolano, Plant Manager
2405 North 2nd Street
Memphis, Tennessee 38127