Inspections, Compliance, Enforcement, and Criminal Investigations

LeRaysville Cheese Factory, Inc. 9/2/16

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 PHILADELPHIA DISTRICT
900 U.S. Customhouse
2nd and Chestnut Streets
Philadelphia, PA 19106
Telephone: 215-597-4390 

 

WARNING LETTER
16-PHI-13
 
 
September 2, 2016
                                                                                                           
 
UPS OVERNIGHT DELIVERY                                                              
RETURN RECEIPT REQUESTED
 
                                                                       
Milton Repsher, Owner
LeRaysville Cheese Factory, Inc.  
42 Cheddar Lane
LeRaysville, PA 18829-7922
 
                                                                                               
Dear Mr. Repsher:
 
The U.S. Food and Drug Administration (FDA) inspected your cheese repackaging facility located at 42 Cheddar Lane, LeRaysville, Pennsylvania, on March 15, 2016 through April 5, 2016. Your firm has significant deviations from the food labeling regulations, Title 21, Code of Federal Regulations (21 CFR), Part 101. These violations cause the cheese products repackaged and distributed by your firm to be misbranded within the meaning of Section 403 of the Federal Food, Drug, and Cosmetic Act (the Act), [21 U.S.C. § 343], in that they are not labeled with the mandatory information required by the Act. 
 
Further, our inspection found serious violations of the Current Good Manufacturing Practice (cGMP) in Manufacturing, Packing, or Holding Human Food, Title 21, 21 CFR, Part 110. These violations cause the cheese products that are repackaged and distributed by your facility to be adulterated within the meaning of section 402(a)(4) of the 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 may find the Act and the referenced CFR regulations through links on FDA’s home page at www.fda.gov.
 
Labeling Violations:
 
Your list of significant violations includes:
 
1.    Your Natural Horseradish Cheddar, Pennsylvania Jack, and Cajun Cheddar Curd products are misbranded within the meaning of section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)], in that the labels fail to bear an adequate common or usual name of the food. Specifically, the statement of identity on the principal display panel (PDP) of your “Cheddar” and “Jack” product labels fail to identify the products with common or usual name of the food as cheese, as required by 21 CFR 101.3(b). 
 
We also note “cheddar cheese” and “Monterey jack cheese” products are standardized foods under 21 CFR 133.113 and 21 CFR 133.153, respectively, and these names should only be used if the food complies with the applicable standard. For example, your Natural Horseradish Cheddar product purports to be a cheddar cheese product but does not appear to meet the requirements for cheddar cheese under 21 CFR 133.113 because natural horseradish flavor, sodium citrate, and whey are not permitted optional ingredients in cheddar cheese. Also, if your Pennsylvania Jack product meets the requirements under 21 CFR 133.153, the correct name of the product as specified by regulation would be “Monterey jack Cheese” or “Monterey cheese”.
 
In addition, your Pepperoni Cheese product appears to be a combination food consisting of a standardized cheese and pepperoni. Because of this, the name Pepperoni Cheese does not appear to be adequate as the name of the standardized cheese used in the product is not included.
 
2.    Your “Pepperoni Cheese” product is misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)], because it is fabricated from two or more ingredients but the labeling fails to bear a complete list of all of the ingredients by common or usual name in descending order of predominance by weight, as well as sub-ingredients, as required by 21 CFR 101.4. Specifically, your “Pepperoni Cheese”” product contains pepperoni, which is a multi-ingredient food. However, the labels do not declare the presence of the sub-ingredients in this multi-component food, as required by 21 CFR 101.4(b)(2).
 
The requirement to list component ingredients (or “sub-ingredients”) may be met by either parenthetically listing the component ingredients after the common or usual name of the multi-component ingredient, or by listing the component ingredients without listing the multi-component ingredient itself. Under the first alternative, the component ingredients must be listed in descending order of predominance within the multi-component ingredient; and under the second alternative, the component ingredients must be listed in descending order of predominance in the finished food, as required by 21 CFR 101.4(b)(2).
 
 
Sanitation Violations:
 
We acknowledge receipt of your letter dated April 21, 2016, written in response to the FDA Form-483, Inspectional Observations, issued to your firm on April 5, 2016. Your response has been made a part of the Philadelphia District’s permanent file for your firm. Our comments regarding the adequacy of the actions you took to correct the objectionable conditions and practices observed during the inspection are detailed after each violation that is noted below.
 
1.    Your firm failed to provide hand washing facilities at each location in the plant where needed, as required by 21 CFR 110.37(e)(1). Specifically, our investigators observed that the portable toilet fails to have suitable hand washing and the employees use a shared door that leads into the Cheese Cutting/Labeling/Packaging/Employee Break/Lunch Room/Office from the outside in order to wash their hands, in the (b)(4) hand washing sink in your facility. Further, the employee performing the duties in the Cheese Cutting/Labeling/Packaging/Employee Break/Lunch Room/Office also performs the duties, on the same shift, associated with your retail operation on the same site. The sharing of these duties requires that the employee from the retail store must enter the Cheese Cutting/Labeling/Packaging/Employee Break/Lunch Room/Office via the same door that another employee who would have used the portable toilet that has no hand washing capabilities. Further, on March 17, 2016, the (b)(4) hand sanitizer installed outside the doorway to the cheese Cutting/Labeling/Packaging/Employee Break/Lunch Room/Office, was observed to be inoperable. Our investigators were informed by an employee that it had been in this condition for “some time”. On March 25, 2016, you informed our investigators that the hand sanitizer was full; however, upon checking it was still inoperable. 
 
This is a repeat observation from the previous inspection of April 2013 and corrective action was promised during a Regulatory Meeting with your firm in July 2013. Further, a letter faxed to FDA from your facility on July 31, 2013, stated that you purchased a hand washing station. This hand washing station was found in its original box, in your firm’s storage room, during our inspection ending April 5, 2016.
 
We acknowledge that your written response states that you placed hand sanitizer in the port a potty, as of April 12, 2016. We do not consider this response an acceptable method of washing and sanitizing hands. Further, you stated that an operational hand sanitizer has been installed outside the door of the packaging room. This will be verified during our next inspection.
 
2.    Your firm failed to provide food handlers appropriate training in proper food handling techniques and food-protection principles to provide a level of competency necessary for production of clean and safe food as required by 21 CFR 110.10(c). Specifically, on July 24, 2013, a Regulatory Meeting was held with your firm and you stated that you planned to provide training to your employee’s. Further, you committed to providing FDA documentation of that training by September 1, 2013; however, the documentation was not provided. Our investigators asked for this documentation during the April 2016 inspection, and you were not able to provide it.
 
We acknowledge that your written response states that training was provided October 23rd, 2012 and you provided documentation of this training. However, this training was provided approximately three years and seven months ago. During the April 2016, our investigators observed and documented that your employees were not following cGMP’s. Therefore, your response is not acceptable and we recommend that all employees, including management received training in cGMP sanitation practices as soon as possible.
 
3.    Your firm failed to ensure work-in-progress is handled in a manner that protects against contamination, as required by 21 CFR Part 110.80(b)(5). Specifically, our investigators observed the following in the cheese Cutting/Labeling/Packaging/Employee Break/Lunch Room/Office:
 
a.  On March 15, 2016, employees were placing 40 lb. blocks of cheese (unwrapped), on the cutting counter, to be cut down into smaller blocks to be repackaged. Approximately two (2) feet away a dish drainer was filled with several bowls and other personal items to include a candle, a roll of clear packing tape with tape dispenser, two (2) spray bottles of (b)(4) All Purpose cleaner, a cloth towel used to wipe down the cutting counter, a plastic container of dishwashing solution, a one (1) gallon plastic container of clear liquid, and an unidentified container.
 
b.  Three (3) employees on (date) and two employees on March 17, 2016, removed the 40 lb. blocks of cheese wrapped in plastic from a cardboard box, placing the block on the cutting table. These employees removed the plastic wrap from the block of cheese, and used their body to maneuver the cheese on the counter. The block of cheese came into direct contact with the employees’ street clothes since no protective outer garments were worn by any of the employees. On March 15, 2016, the 40 lb. blocks of cheese that were cut down into smaller blocks were Monterey Jack and Pepperoni Monterey Jack. 
 
c.  Our investigators observed a yellow colored substance around and encased in the open areas of the cheese cutting apparatus. You informed our investigator that (b)(4) Glue was used to fix the cracks and a sealant placed over the glue. Our investigators determined that the (b)(4) Glue is not food grade and were unable to determine if the sealant was food grade. Further, underneath this apparatus, the wire used to cut the cheese was observed in contact with non-food contact surfaces; specifically, metal framework. When the cheese cutter was not in use, the plastic handle of the wire cutter and the wire were observed hanging over the edge of the table and at times touching the plastic PVC piping, which was covered with cheese particles and other debris.
 
d.  Eight (8) open packages of sliced blocks of cheese, on a blue/grey cart, were observed next to an employee’s pink travel mug that was sitting next to the cheese on the same cart. 
 
We acknowledge that your written response states that these violations have been corrected and that your response also provided a document entitled “Cheezsorce; Good Manufacturing Practices For Dairy Processing Plants”. This document is a guideline established to assure that food products are manufactured and stored under safe and sanitary conditions. During our next inspection, our investigators will verify that all deviations have been corrected and that you are regularly implementing the cGMP practices discussed in this document. 
 
4.    Your employees failed to wash hand thoroughly in an adequate hand-washing facility before starting work to protect against the contamination of food as required by 21 CFR 110.10(b)(3). Specifically, on March 15, 2016, our investigators observed an employee return to the cheese Cutting/Labeling/Packaging/Employee Break/Lunch Room/Office after helping a customer in the retail store. This employee started to wash her hands but was told by another employee to stop washing her hands and put gloves on because the drain in the floor was backing up due to a broken pipe behind the building. This employee stopped washing her hands and went back to work packaging cheese for shipments to customer without wearing gloves.
 
We acknowledge that your written response states that the cheese in question was already prepackaged and that your employee had no physical contact with unpackaged cheese, after assisting a customer in your retail store. We do not consider this response adequate. Your employee returned to the cheese cutting area from another task in your retail store, and should have washed her hands and put on gloves prior to working with the cheese. As previously stated, our investigators will verify that you are regularly implementing cGMP practices, during our next inspection. 
 
5.    Your employees failed to confine beverages to areas other than where food may be exposed, as required by 21 CFR 110.10(b)(8). Specifically, on March 15, 2016, our investigators observed an employee in the cheese Cutting/Labeling/Packaging/Employee Break/Lunch Room/Office put her gloves on and say “Wait a minute I have to finish this”. The employee picked up a bottle containing a pink liquid, took the lid off, and drank the contents while standing next to the cheese cutting table, which had blocks of unwrapped cheese sitting on the table. The employee then proceeded to cut and handle unwrapped cheese without washing her hands or changing her gloves.
 
We acknowledge that your written response states that your employees have been advised that there must be no eating or drinking in the packaging room. Your response failed to address that the employee break/lunch room has been temporarily moved to a manufacturing room which currently is not being used. You informed our investigators that you plan to remodel this room so that you can eventually begin to manufacture cheese, at your facility again. We question how you will handle the location of the employee break/lunch room once remodeling begins. 
 
6.    Your employees failed to use gloves in food handling that were maintained in an intact, clean, and sanitary condition to protect against the contamination of food, as required by 21 CFR 110.10(b)(5). Specifically, on March 15, 2016 and March 17, 2016, our investigators observed several employees in the cheese Cutting/Labeling/Packaging/ Employee Break/Lunch Room/Office who failed to change gloves between different tasks. These employees were observed handling boxes of blocks of cheese from the cooler storage area, transporting the boxes into the cheese Cutting/Labeling/Packaging/Employee Break/Lunch Room/Office, opening the cardboard boxes and removing and unwrapping the blocks of cheese, without changing their gloves or washing their hands.   
 
We acknowledge that your written response states that you informed your employees that anytime they perform a separate task they need to throw away the old gloves, wash their hands, and put on new gloves. During our next inspection, our investigators will verify that your employees are regularly implementing cGMP practices discussed in this deviation.  
 
7.    Your employees failed to remove unsecured jewelry or other objects which might fall into food, equipment and containers, as required by 21 CFR 110.10(b)(4). Specifically, on March 15, 2016, our investigators observed three (3) employees in the cheese Cutting/Labeling/ Packaging/ Employee Break/Lunch Room/Office wearing jewelry. One employee was observed to be wearing multiple pairs of earrings, necklaces, and rings. A second employee was observed wearing a ring and earrings, and a third employee was observed wearing a necklace, three rings, and a pair of earrings.
 
We acknowledge that your written response states that you informed your employees that they will not wear jewelry when packaging cheese. During our next inspection, our investigators will verify that your employees are regularly implementing cGMP practices discussed in this deviation.  
 
8.    Your firm failed to adequately store personal belongings so that they were not in an area where food is exposed, as required by 21 CFR 110.10(b)(7). Specifically, on March 15, 2016, our investigators observed:
 
a.  In the Cooler Storage room, the following items were stored on a shelf: A bottle of ranch salad dressing, a bottle of flavored water, bottle of water, can of blueberry pie filling, plastic squeeze container of mustard, plastic bag of cheese curds, three jars of pickled garlic, jar of salsa, bottle of cod liver oil, and four packages of various cheeses. Under this shelf was a bottle of water near several blocks of wrapped cheese and a black plastic storage container, which contained Greek yogurt, fruit cups, container of cheese spread, and other personal food items. Further, on storage shelf was an empty can of diet soda stored near finished product, and on a third storage shelf was a bottle of coconut water stored near finished product. Additionally, on a table there was an approximate half case of unopened bottles of water and fall decorations and table cloths stored in an open box.
 
b.  In the cheese Cutting/Labeling/Packaging/ Employee Break/Lunch Room/Office, the following was observed: Two employee’s cooler type bags containing various personal food items on the back table. In addition, there was a microwave and coffee pot on the table. Under this table there were two propane type gas tanks. This was a repeat observation from the April 2013 inspection. Further, there was a can of odor eaters and a container of personal hygiene powder on the back window sill.
 
We acknowledge that your written response states that these violations have been corrected and that employees have been informed that no personal items will be stored and brought into rooms that cheese is being packaged or stored in. During our next inspection, our investigators will verify that all deviations have been corrected and that you are regularly implementing the cGMP practices.
 
9.    Your firm failed to properly identify and store toxic cleaning compounds in a manner that protects against contamination of food, food contact surfaces, and food-packaging materials, as required in 21 CFR 110.35(b)(2). Specifically, on March 15, 2016, our investigators observed a container of (b)(4) wipes stored in the Cooler storage area, on a shelf next to finished product; a spray bottle of (b)(4) All Purpose Cleaner; and a towel used for cleaning the cheese cutting table near exposed finished product in the cheese Cutting/Labeling/Packaging/ Employee Break/Lunch Room/Office.
 
We acknowledge that your written response states that these violations have been corrected and that employees have been informed that no cleaning supplies will be permitted to be kept on the packaging table while packing cheese. This response is not acceptable in that you must have a segregated area for all cleaning supplies. Cleaning supplies must not be kept on the packaging table even when cheese is not being packaged. 
 
10.    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 March 15, 2016, our investigators observed shelving, both mobile and stationary in the Cooler storage room, to have rust and chipped/peeling paint where finished product was stored. Further, in the cheese Cutting/Labeling/Packaging/ Employee Break/Lunch Room/Office a window was broken and another window was covered with more than a dozen dead insects. Additionally two of the wall mounted document holders above the cheese cutting apparatus had a build-up of foreign material, a rusty nail, and a crack in the holder. These document holders are located in close proximity to where the blocks of cheese are cut. 
 
We acknowledge that your written response states that you ordered a new window for the packaging room and other deviations have been corrected. Further, you state that you are in the process of remodeling the manufacturing room and from there you will remodel your cooler storage area. During the inspection of May 2013, your firm was informed about removing items from your facility that had rust, and chipped/peeling paint. Further, you promised corrective action regarding this issue during our Regulatory Meeting with your firm in July 2013. We are concerned that almost three years later; our investigators continue to find these recurring deviations.
 
11.    Your firm failed to construct your plant in such a manner as to allow floors, walls, and ceilings to be adequately cleaned and kept clean and in good repair, as required by 21 CFR 110.20(b)(4). Specifically,
 
a.  On February 27, 2014, our investigators observed that the door from the manufacturing room to the boiler room had a rust build up at the bottom of the door; this door had rusty scratches covering the middle section of the door; the door knob was missing, and the door knob hole is covered with duct tape. Additionally, the mobile steps leading from the manufacturing room into the shipping container storage area and the mobile steps leading from the manufacturing area to the raw milk area were rusty. Further, tape that covers the seams on the ceiling of the manufacturing room was peeling and hanging, leaving exposed seams; and pipes running throughout the manufacturing room have paper covered insulation on them and repairs have been made using duct tape. We note that these violations are repeat observations from the previous inspection of April 2013, and your firm was manufacturing cheese in this room from July 2013 until February 2015. Lastly, the floor in the manufacturing area was observed with several deteriorated areas of flooring in various sizes, ranging from a few inches to a couple feet in diameter. These areas were no longer a smooth or cleanable surface and the areas where concrete was left exposed, had water accumulating under the remaining floor surrounding these areas. Our investigators were unable to determine how long the water had been accumulating under the floor, since your firm stopped manufacturing in this room in February 2015. We acknowledge that you indicated, during the Regulatory Meeting of July 2013, that you replaced this floor with a USDA approved epoxy floor in September 2012.
 
b.  On March 15, 2016 and March 17, 2016, in the cooler room, the pipes running throughout the room have paper covered insulation on them and repairs have been made to them using duct tape.
 
c.  On March 15, 2016, in the cooler storage room, the door leading into a storage room had rust on the bottom and chipped/peeling paint on various locations of the door. Further, the door frame was covered with a black mold-like substance; had white peeling tape hanging from the frame; and the upper corners appeared to have rotting wood present.
 
We acknowledge that your written response states that the manufacturing room has not been used since January 2015, and is under renovation. We do not consider this response acceptable. Your employees are currently using this room as a break/lunch room and after using this room, return to other areas of your facility. You must maintain this area as a part of your facility and it must comply with all applicable cGMP’s. 
 
The violations mentioned in this letter are not intended to be an all-inclusive list of violations at your facility. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations. You should take prompt action to correct the violations described above and prevent their further recurrence. Failure to promptly correct these violations may result in legal action, without further notice, including, but not limited to, seizure and/or injunction against the manufacturers and distributors of violative products.
 
We also have the following labeling comments:
  • Your cheddar, jack, curd, and “Pepperoni Cheese” products fail to declare the net quantity of contents on the principal display panel (PDP) in accordance with 21 CFR 101.105.
  • “Your Natural Horseradish Cheddar, Pennsylvania Jack, and Cajun Cheddar Curd products fail to list the place of business’s street address.  In accordance with 21 101.5(d), the statement of the place of business must include the street address, unless the street address is shown in a current city directory or phone directory.  The current inspection also revealed your firm is not manufacturing the products that you distribute. In accordance with 21 CFR 101.5(c), where the food is not manufactured by the person whose name appears on the label, the name shall be qualified by a phrase that reveals the connection such person has with such food; such as "Manufactured for ___", "Distributed by ___", or any other wording that expresses the facts. 
Further, Section 743 of the Act, 21 U.S.C. § 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 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.
 
Please notify this office in writing, within fifteen (15) working days from your receipt of this letter, of the specific things that you are doing to correct the violations described above. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.
 
Your written response should be sent to Richard C. Cherry, Compliance Officer, at the address on this letterhead. If you have any questions about this letter, please contact Mr. Cherry at 215-717-3075 or email him at Richard.Cherry@fda.hhs.gov.                                                                                   
 
Sincerely,
/S/ 
Anne E. Johnson
District Director                                                                      
Philadelphia District
 

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