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  5. Frito Lay Inc - 08/04/2015
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Frito Lay Inc

Frito Lay Inc

United States

Issuing Office:
New Orleans District Office

United States


Department of Health and Human Services logoDepartment 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


August 4, 2015
Delivery Signature Requested
Tom Rao, Regional Vice President of Operation
Frito-Lay, Inc.
7701 Legacy Drive
Plano, Texas 75024
Dear Mr. Rao:
On May 26-27, and June 1, 2015, a U.S. Food and Drug Administration (FDA) investigator inspected your snack food manufacturing facility, located at 298 Industrial Boulevard, Pulaski, Tennessee.  The inspection revealed serious violations of FDA’s Current Good Manufacturing Practice requirements in Manufacturing, Packing, or Holding Human Food, Title 21, Code of Federal Regulations, Part 110 (21 CFR 110). These conditions cause the food products held at your facility to be adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 United States Code (USC) 342(a)(4)] because they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health. You may find the Act and its implementing regulations through links on FDA’s Internet homepage at www.fda.gov.
We acknowledge receipt of your firm’s response to Form FDA 483 on June 15, 2015. Your response included a number of corrective actions, which you either state you have taken or plan on taking to address the issues noted during the inspection (such as modifications and repairs to the equipment and the building). We will verify the adequacy of these corrective actions during our next inspection of your firm. Violations revealed during the inspection include, but are not limited to:
1.    You must maintain buildings, fixtures, or other physical facilities in a sanitary condition and kept in repair sufficient to prevent food from becoming adulterated within the meaning of the Act, to comply with 21 CFR 110.35(a). However, during our inspection, our investigators observed the following examples of your facility and building in a poor state of repair:
a.    At least 16 (b)(4) to collect water due to apparent leaks in the roof were observed suspended from the ceiling and often directly over exposed product throughout the facility.
b.    The equipment wash and sanitize bay, walls and floor, located in the pretzel processing area appeared worn and soiled. An exposed hole at least 3” in diameter was observed in the interior cinder block wash of the wash bay.
c.    The air duct work in the pretzel processing area and above pretzel processing equipment over exposed food product was observed wrapped in plastic sheeting and secured with duct tape.
d.    The interior ceiling in the production areas throughout the facility was observed with numerous spots where the paint was peeling and missing. The ceiling area directly above the mixing deck to processing lines where batches of cookies and crackers are mixed and transferred was observed with apparent water stains, missing paint, and a water diverter/diaper.
e.    The interior walls in the production areas throughout the facility were observed with numerous spots where the paint was peeling and missing.
f.    The opening where the incline conveyor transfers popcorn from the processing room to the packaging room appeared to have chipping and missing paint directly above exposed ready-to-eat product.
g.    A water hose bib was observed leaking onto the processing floor in the popcorn processing area within approximately five feet of processing equipment.  
h.    Apparent water and/or condensation from an unidentified source was observed at the base of the access door (hinge side) and floor located inside the (b)(4).
i.    The metal piping of the votator, located on the mixing deck, had areas of adhering product which appeared to be leaking from at least two pipe connection points.
j.    The transfer pump attached to the (b)(4), located on the mixing deck, had areas of adhering product which appeared to be leaking from a seal. Apparent food product was also observed dripping from the seal and onto the floor. 
k    Apparent chocolate chip cookie dough was observed leaking from a pinch point on the dough hopper located on (b)(4) processing line.
l.    At least 3 cheese filling machines located on line (b)(4) had areas of adhering product which appeared to be leaking from pump seals during the manufacturing of product code (b)(4).     
m.    The metal piping used to transfer cooking oil attached to the popcorn processing equipment within three feet of ready-to-eat popcorn had areas of adhering product which appeared to be leaking from at least two pipe connection points. Additionally, loosely secured heat tape with an end wrapped in electrical tape appeared to be soiled with adhering debris.
n.    Apparent missing and chipping paint was observed on the (b)(4) processing equipment directly above food product. Additionally, on same processing equipment, an electrical connection with exposed wiring in conduit was observed to be wrapped with duct tape.
o.    Apparent corrosion and adhering debris was observed on the protective fan shrouds located inside the (b)(4) and above ready-to-eat product. Additionally, the ceiling immediately in front of the fan shrouds appeared to be soiled with apparent dust.
p.    The interior walls and fixtures throughout the majority of the production area including but not limited to: walls, baseboards, and support beams appeared to be soiled with apparent food debris and dust.
q.    The mezzanine floors above the (b)(4) packaging line, (b)(4) packaging line, and pretzel/popcorn packaging line appeared to be soiled with adhered product, dust, and debris.
r.    The framing of the line (b)(4) processing line, (b)(4) incline leading to mezzanine, (b)(4) packaging lines, (b)(4) processing line located above mezzanine, and pretzel/popcorn packaging line located above the mezzanine appeared to be soiled with adhering product, dust, and debris.
s.    Apparent food and other debris were observed on an interior wall, base board, floor, and metal pole along and within five feet of packaging line (b)(4).
2.    Your plant and facility must be constructed in such a manner that floors, walls, and ceilings may be adequately cleaned and kept clean and kept in good repair; that drip or condensate from fixtures, ducts, and pipes does not does not contaminate food, food contact surfaces, or food packaging materials, to comply with 21 CFR 110.20(b)(4). However, piping approximately four feet above a conveyer transferring ready to eat product from the cooler to packaging line (b)(4), appeared to have condensate and water stains on the underside of the piping directly above the product.
3.    Your firm must clean all food contact surfaces, including utensils and food contact surfaces of equipment, as frequently as necessary to protect against contamination of food, to comply with 21 CFR 110.35(d). However, on May 26, 2015, food contact surfaces were observed to be soiled with adhering food as follows:
a.    The conveyor belting and support rollers on processing line (b)(4) decline area, during the manufacturing of “Grandma’s Large Vanilla Cream” cookies (with product code (b)(4), appeared soiled with adhering food. The apparent adhering food was observed falling onto ready-to-eat cookie bases (wafers) and into the rework chute. The underside of catch pan hanging directly above same ready-to-eat "cookie bases" was also observed with adhering product.
b.    The conveyor belting on processing line (b)(4) immediately before the (b)(4) (cooler) appeared soiled with adhering food and directly touching ready-to-eat product.
c.    The proofer belting on the pretzel processing line appeared soiled with adhering food embedded in the belting. Production was between batch runs and was ready for use for the next production run.
4.    You must take all reasonable precautions to ensure that production procedures do not contribute contamination from any source, to comply with 21 CFR 110.80. However, the underside of the plastic sheeting (which was secured with duct tape to the conveyor belting frame on processing line (b)(4) was observed touching ready-to-eat "cookie bases" as adhered food debris would fall onto the sheeting. Plastic sheeting was also observed to be secured with duct tape covering product transfer equipment (at the rework conveyer on processing line (b)(4) used to manufacture “Grandma’s Large Vanilla Cream” cookies of product code (b)(4)
5.    You must take all reasonable measures and precautions to ensure that all persons working in direct contact with food, food contact surfaces, and food packaging materials, shall conform to hygienic practices while on duty to the extent necessary to prevent the contamination of food, including washing hands thoroughly when hands may have become soiled or contaminated, to comply with 21CFR 110.10(b)(3). However, the following was observed:
a.    An employee on processing line (b)(4) was observed touching non-food contact surfaces, processing line framing, that appeared soiled with adhering food and then handling ready-to-eat product during processing and prior to packaging.
b.    An employee, on processing line (b)(4) prior to the pinch point referenced as the (b)(4) was observed wiping their hands on their pants, then resting hands on non-food contact processing line framing, and handling ready to eat product during processing and prior to packaging of product (b)(4) 
6.    Your plant must be equipped with plumbing which is maintained to avoid constituting a source of contamination to food, to comply with 21 CFR 110.37(b)(3). However, a (b)(4) water metering controller, located on the mixing deck, used to (b)(4) appeared to be oxidized and leaking.   
7.    You must store liquid and dry raw materials in a manner which protects against contamination, to comply with 21 CFR 110.80(a)(7). However, the following was observed:
a.    The approximately (b)(4) soda tank appeared to be leaking with apparent liquefied caustic soda product on the floor.
b.    The corn oil tank, located next to the liquid caustic soda tank, appeared to have at least two leaking pipe fittings with apparent corn oil leaking and running down the side and accumulating in the bottom of the tank support. 
8.    Your plant building must be constructed in a manner to provide adequate screening or other protection against pests, to comply with 21 CFR 110.20(b)(7). However, a non-continuous gap was observed between the floor and the roll up door (identified as “2”) leading from the outside to the pretzel and popcorn staging area which was large enough to allow for ingress of pests (measuring approximately 24" x 1/4", 2" x 1/4", 4" x 1/4", 2" x 1/4", 6" x 1/4", and 8" x 1/4").
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product and/or enjoin your firm from operating.
Please notify this office in writing within 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 actions you have taken. If your planned corrections will occur over time, please include a timeframe for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time in which the corrections will be completed.
This letter may not list all the violations at your facility. You are responsible for ensuring your processing plant operates in compliance with the Act and the Current Good Manufacturing Practice regulation (21 CFR 110).  You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Section 743 of the Act, [21 USC 379j-31], authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs.  A re-inspection is one or more inspections conducted subsequent to an inspection that identified non-compliance 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 non-compliance materially related to a food safety requirement of the Act.  Accordingly, FDA may assess fees to cover any re-inspection-related costs.
Your reply should be directed to the U.S. Food and Drug Administration, Attention:  David Van Houten, Compliance Officer, at the above address. If you have questions, concerning the contents of this letter, you may contact Mr. Van Houten at (615) 366-7813.
Sincerely yours,
Ruth P. Dixon
District Director
New Orleans District
cc: Randall L. Brezinski, Manufacturing Director
      Frito-Lay, Inc.
      298 Industrial Boulvard
      Pulaski, Tennessee 38478-5220

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