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WARNING LETTER

Mama Turney's Homemade Pies, Inc. MARCS-CMS 513825 — 11/01/2017

Mama Turney's Homemade Pies, Inc. - 513825 - 01/11/2017


Delivery Method:
United Parcel Service

Recipient:
Recipient Name
Sanuel H. Howard
Mama Turney's Homemade Pies, Inc.

5205 Maryland Way, Suite 201

Brentwood, TN 37027
United States

Issuing Office:
New Orleans District Office

United States


 

  

Black HHS-Blue FDA Logo

 

 

 
New Orleans District
404 BNA Drive, Ste 500
Nashville, TN 37217 

 

January 11, 2017
 
WARNING LETTER NO. 2017-NOL-03
 
UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
 
Samuel H. Howard, Co-Owner
Mama Turney’s Homemade Pies, Inc.
5205 Maryland Way, Suite 201
Brentwood, Tennessee 37027
 
Dear Mr. Howard:
 
On October 11-13, and 18, 2016, a U.S. Food and Drug Administration (FDA) investigator inspected your bakery, located at 5470 Buena Vista Road, Whites Creek, 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 through links on FDA’s Internet home page at www.fda.gov.
 
Violations revealed during the inspection include, but are not limited to, the following:
 
1.    Your firm failed to take effective measures to exclude pests from the processing areas and to protect against the contamination of food on the premises by pests, as required by 21 CFR 110.35(c). Specifically, our investigator discovered evidence of live insect activity in, on, and near foods stored in your food processing facility. For example, the following items were discovered in the production areas of the bakery during the inspection:
  • On 10/13/2016, a live fly was observed resting on the pie shells and on the pie filling of finished baked 3” pecan pies, which were staged on a sheet pan for cooling in the Cooling Area.
  • On 10/11/2016, a live fly was observed resting on a pie rack containing baked 9” chocolate pies, which were staged for cooling in the Cooling Area.
  • On 10/11/2016, two live flies were observed inside a cardboard packaging box used to package a case of baked 9” chess pies in the Wrapping/Packing Area.
  • On 10/11/2016, a live fly was observed on the container lids used to package baked 9” pies in the Wrapping/Packing Area.
  • On 10/11/2016, a live fly was observed on a portable fan used in the Wrapping/Packing Area; the fan was approximately 3’-4’ from baked 9” chocolate pies.
  • On 10/13/2016, a live fly was observed resting on the 3” pie wrapping machine in the Wrapping/Packing Area; the wrapping machine was used to package baked 3” pies.
  • On 10/12/2016, an apparent stinkbug insect was observed crawling down a storage rack containing baked 9” lemon chess pies that had been packaged in the Wrapping/Packing Area.
  • On 10/11/2016, approximately three apparent rodent excreta pellets (AREPs) were observed underneath the mop sink in the northwest corner of the production area during the manufacture of 9” chocolate pies.
This is a repeat observation from the 4/14/2009 and 9/20/2010 FDA inspections.
 
2.    Your firm failed to require personnel to wash their hands thoroughly in an adequate hand-washing facility before starting work, after each absence from the work station, and at any other time when the hands may have become soiled or contaminated, as required by 21 CFR 110.10(b)(3). Specifically,
  • On 10/13/2016, an employee was observed returning from outdoors and removing baked 3” chess pies from the oven to stage for cooling in the Cooling Area without cleaning and sanitizing his hands.
  • On 10/12/2016, employees were observed arriving for duty and proceeding directly to their work station in the Wrapping/Packing Area without cleaning and sanitizing their hands.  Baked 3” and 9” pies were wrapped and packaged in this area.
  • On 10/11/2016, an employee filling unbaked pie shells with chocolate filling was observed leaving the Preparation/Mixing Area for a break, and then resuming pie filling upon his return to the area without washing and sanitizing his hands.
  • On 10/11/2016, on at least three occasions, an employee was observed leaving the Preparation/Mixing Area to discard cardboard soiled with food debris in the waste bin outdoors.  The cardboard had previously been resting atop rubber mats on the floor in the Preparation/Mixing Area.  The employee returned to the workstation and resumed filling unbaked pie shells with chocolate filling without washing and sanitizing his hands.
  • On 10/11/2016 and 10/12/2016, there were six separate occasions where an employee was observed taking bagged trash to the outdoor waste bin and then resuming pie filling for unbaked chocolate and chess pies upon return to the Preparation/Mixing Area without washing and sanitizing his hands.
  • On 10/12/2016, an employee was observed eating a breakfast sandwich and drinking a beverage in the Wrapping/Packing Area.  The employee returned to his work station in the Preparation/Mixing Area and began preparing the work station for manual pouring of pie filling into unbaked 9” pie shells without washing and sanitizing his hands. 
3.    Your firm failed to perform packaging in a manner that protects food from becoming contaminated, as required by 21 CFR 110.80(b)(13).  Specifically,
  • On 10/13/2016, packaging material, which is fed through the 3" pie-wrapping machine, was observed in direct contact with the floor soiled with food debris, in the Wrapping/Packing Area.  This packaging material came into direct contact with baked 3” pies during wrapping.
  • On 10/13/2016, labels being affixed to 9” pie containers were observed in direct contact with the floor, which was soiled with food debris, in the Wrapping/Packing Area.
4.    Your firm failed to clean and sanitize utensils and equipment in a manner that protects against contamination of food, food contact surfaces, or food-packaging materials, as required by 21 CFR 110.35(a).  Specifically,
  • On 10/12/2016, an employee working in the Preparation/Mixing Area was observed cleaning and sanitizing a (b)(4) preparation table with a bowl containing a germicidal bleach and water solution.  The employee was observed dipping a rag into the solution and wiping the table with the rag while unbaked 9” pie shells were stored on the table.  The rag was observed to come into direct contact with the unbaked 9” pie shell while the employee was wiping the table.
  • On 10/12/2016, an employee working in the Preparation/Mixing Area was observed scraping food debris off baking sheet pans with a scraping knife into a trash can.  The baking sheet pans came into direct contact with a trash can during scraping.  The sheet pans were not cleaned or sanitized after contact with the trash can before unbaked 9” pie shells were placed onto the sheet pans for manual pouring of pie filling. 
5.    Your firm failed to clean non-food-contact surfaces of equipment as frequently as necessary to protect against contamination, as required by 21 CFR 110.35(d)(3). Specifically,
  • On 10/11/2016, an accumulation of dust and food debris was observed on an approximately (b)(4) pedestal fan which was in operation and was being used to cool baked 9” pies prior to wrapping and packaging.  The fan was operating less than 5 inches from the baked pies staged in racks for cooling in the Cooling Area.
  • On 10/11/2016, an accumulation of dust approximately ¼” - ½” thick was observed inside an air duct which was blowing out directly above baked 9” chocolate pies stored in pie racks in the Cooling Area. 
This is a repeat observation from the 9/20/2010 FDA inspection.
 
6.    Your employees failed to confine beverages and food consumption to areas other than where food may be exposed, as required by 21 CFR 110.10(b)(8).  Specifically,
  • On 10/11/2016, an employee was observed drinking a beverage immediately adjacent to exposed 9” unbaked pie shells stored on a preparation table in the Preparation/Mixing Area.
  • On 10/12/2016, a beverage and breakfast sandwich were observed on a (b)(4) table in the Wrapping/Packing Area where baked 3” chess pies were being wrapped and packaged.  An employee was observed eating this breakfast sandwich and placed these items on this table during his break.
7.    Your firm failed to provide adequate screening or other protection against pests, as required by 21 CFR 110.20(b)(7).  Specifically,
  • On 10/11/2016, 10/12/2016, and 10/13/2016, the exit door leading outside from the production area was without a screen and the door was continuously open throughout the production of 3” and 9” pies (chocolate, chess, and pecan pies).
  • On 10/11/2016, an unscreened opening, approximately 3" in diameter, was observed on a pipe leading from the south side of the building exterior to the production area.
This is a repeat observation from the 4/14/2009 and 9/20/2010 FDA inspections.
 
8.    Your firm failed to maintain equipment in an acceptable condition through appropriate cleaning and sanitizing, as required by 21 CFR 110.80(b)(1).  Specifically,
  • On 10/11/2016, 10/12/2016, and 10/13/2016, an accumulation of food debris was observed on the 3” pie-wrapping machine in the catch, on the track, and in the shrink-wrap tunnel.  Baked 3” pies move via conveyor through the 3” wrapping machine during wrapping.  These observations were noted after the previous day’s production run and prior to production startup on each of the aforementioned dates.  Production commenced without removal of the observed food debris.
  • On 10/11/2016, 10/12/2016, and 10/13/2016, an accumulation of food debris was observed in the conveyor tunnel and on the framework of the 9” pie-wrapping machine.  Baked 9” pies move via conveyor through the tunnel during wrapping.
These observations were noted after the previous day’s production run and prior to production start-up on each of the aforementioned dates.  Production commenced without removal of the observed food debris.
 
This is a repeat observation from the 9/20/2010 FDA inspection.
 
9.    The plant is not constructed in such a manner as to allow floors, walls and ceilings to be adequately cleaned and kept clean and kept in good repair, as required by 21 CFR 110.20(b)(4).  Specifically,
  • On 10/12/2016, two holes, approximately 2’ and 4’ in diameter, were observed in the ceiling above the oven.  Exposed electrical wiring and insulation was hanging from these holes.  Baked, unwrapped 3” pecan pies were stored on a rack within close vicinity of these holes and the exposed wiring.
  • On 10/13/2016, missing floor tiles were observed in the Wrapping/Packing Area during the wrapping and packaging of exposed 3” and 9” pies.
This is a repeat observation from the 9/20/2010 FDA inspection.
 
10.    Your firm failed to provide safety-type lighting fixtures suspended over exposed food, as required by 21 CFR 110.20(b)(5). Specifically,
  • On 10/12/2016, a baking rack containing uncovered baked 3" pecan pies was observed in the Wrapping/Packing Area beneath a light fixture that was missing its safety shield.
11.    Your firm failed to provide sufficient space for placement of equipment and storage of materials as necessary for the maintenance of sanitary operations and the production of safe food, as required by 21 CFR 110.20(b)(1).  Specifically,
  • On 10/11/2016, packing boxes for finished 9" pies were stored in the employee restroom.
  • On 10/12/2016, packaging boxes for finished 9” pies were stored inside the conveyor tunnel on the 9” wrapping machine in the Wrapping/Packing Area.  Food debris accumulation was observed inside the tunnel after the previous day’s production run and prior to production start-up of this equipment.
  • On 10/11/2016, 10/12/2016, and 10/13/2016, the 9” pie-wrapping machine in the Wrapping/Packing Area was oriented immediately adjacent to the administrative area.  Office files and equipment were observed atop the wrapping machine where 9” pies were exposed for wrapping and packing.
12.    Employees failed to wear appropriate hair restraints in an effective manner, in accordance with 21 CFR 110.10(b)(6). Specifically,
  • On 10/11/2016, 10/12/2016, and 10/13/2016 employees working in the Preparation/Mixing Area were observed with facial hair and were not wearing beard covers while manually pouring chocolate, chess, and pecan pie filling into pie shells. 
13.    Your firm failed to properly store toxic cleaning compounds, sanitizing agents and pesticide chemicals in a manner that protects against contamination of food, as required by 21 CFR 110.35(b)(2).  Specifically,
  • On 10/11/2016 and 10/12/2016, 1-gallon containers of cleaning and sanitizing chemicals (such as germicidal bleach and liquid pot and pan detergent) and 16-ounce bottles of pesticide spray were observed on crates immediately adjacent to a deep freezer in the Preparation/Mixing Area.  Mixing of raw ingredients (such as (b)(4) sugar and cocoa powder) for the production of 9” chocolate pies was being performed atop the lid of the deep freezer.
14.    Your firm failed to maintain buildings, fixtures, or other physical facilities in a sanitary condition, as required by 21 CFR 110.35(a).  Specifically,
  • On 10/11/2016, 10/12/2016, and 10/13/2016 accumulations of trash and food debris, which had not been removed after each day’s production, were observed on the flooring underneath and around shelved storage containing finished product, finished product labeling, and finished product packaging material.  Trash and food debris were also observed underneath and around the 3” and 9” pie wrapping machines in the Wrapping/Packing Area where baked 3” and 9” pies were exposed for wrapping.
This is a repeat observation from the previous 9/20/2010 FDA inspection.
 
15.    Your employees failed to store personal belongings to areas other than where food may be exposed or where utensils are washed, as required by 21 CFR 110.10(b)(7).  Specifically,
  • On 10/11/2016 and 10/12/2016, personal food and beverage items (such as soda, juice, water, and condiments) were observed on the shelving underneath a (b)(4) preparation table in the Preparation/Mixing Area during the production of 3” and 9” pies (chocolate, chess, and pecan).
  • On 10/11/2016, a beverage was observed on a stainless steel table in the Preparation/Mixing Area while employees were manually pouring chocolate filling in the unbaked 9” pie shells to prepare them for baking.
  • On 10/11/2016, a beverage was observed atop the 9” pie-wrapping machine in the Wrapping/Packing Area where baked 3” chess pies were exposed on the 3” pie-wrapping machine during wrapping and packaging.
  • On 10/13/2016, a beverage was observed on a stainless steel table in the Preparation/Mixing Area immediately adjacent to exposed unbaked 9” pie shells.
16.    Your firm failed to properly store equipment and remove litter and waste that may constitute an attractant, breeding place, or harborage area for pests, within the immediate vicinity of the plant buildings or structures, as required by 21 CFR 110.20(a)(1).  Specifically,
  • On 10/11/2016, a set of pallets was observed immediately adjacent to the exterior wall on the south side of the building.
  • On 10/11/2016, an out-of-service refrigerator was observed immediately adjacent to the exterior wall on the south side of the building.  The refrigerator contained a 3” chocolate pie, which appeared to contain mold.  A single apparent rodent excreta pellet (AREP) appeared to be lying just adjacent to the pie.
  • On 10/13/2016, cardboard boxes and pallets not present on previous inspection days were observed immediately adjacent to the exterior wall on the south side of the building.
Finally, the above listed violations are not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to ensure your facility is operated in a sanitary manner.
 
The specific violations noted in this letter and in the FDA 483, issued at the close out of the inspection, may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.
 
We received your firm’s response to the Form FDA 483 dated October 21, 2016, and have determined your response is inadequate.  You have not provided evidence such as photographs, receipts, and/or training documentation to show you have corrected any of the violations observed.  
 
You should take prompt action to correct these violations. Failure to promptly correct and prevent the recurrence of these deviations may result in regulatory action such as a seizure or injunction. 
 
You should respond in writing within 15 working days from the date you receive this letter. Your response should include 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 correction 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 response should be comprehensive and address all violations included in this Warning Letter.
 
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 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)]. 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 send your reply to the U.S. Food and Drug Administration, 404 BNA Drive, Ste 500, Nashville, TN 37217, Attention:  Kimberly Dutzek, Compliance Officer. If you have questions regarding any issues in this letter, please contact Ms. Dutzek via (615) 366-7826.
 
Sincerely,
/S/ 
Ruth P. Dixon
District Director
New Orleans District
 
  
cc:    Michael E. Turney, Co-owner
         Mama Turney’s Homemade Pies, Inc.
         5470 Buena Vista Rd.
         Whites Creek, TN 37189-9065