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WARNING LETTER

Bluegrass Proteins, Inc. MARCS-CMS 533552 — Oct 26, 2017

Bluegrass Proteins, Inc. - 533552 - 10/26/2017


Delivery Method:
UPS

Recipient:
Recipient Name
Hoyt Huffman
Bluegrass Proteins, Inc.

1117 Cleveland Avenue

Glasgow, KY 42141
United States

Issuing Office:
Minneapolis District Office

United States


 

  

Black HHS-Blue FDA Logo

 

 

 
 

 

October 26, 2017
 
 
WARNING LETTER
 
 
Via UPS Overnight Delivery                                                        Refer to CMS 533552
 
 
Hoyt Huffman
Chief Executive Officer
Bluegrass Dairy and Foods, Inc.
1117 Cleveland Avenue
Glasgow, Kentucky 42141
 
Dear Mr. Huffman:
 
The United States Food and Drug Administration (FDA) conducted an inspection of your milk-based powder manufacturing facility located at 1864 311th Avenue, Dawson, Minnesota, 56232-4216, from May 22 to June 12, 2017. During the inspection FDA collected environmental samples from various areas in your processing facility, including areas that are in close proximity to food and food-contact surfaces.  FDA laboratory analysis of the environmental samples (i.e., swabs) identified the presence of Salmonella, a human pathogen, in your facility.  Additionally, FDA investigators observed violations of Current Good Manufacturing Practice (CGMP) in Manufacturing, Packing, or Holding Human Food regulation, Title 21, Code of Federal Regulations, Part 110 (21 CFR 110).[1]  Based on FDA’s analytical results for the environmental samples and inspectional findings documented during the inspection, we determined that your food products are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4), in that they are 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 FDA’s regulations through links on FDA’s home page at www.fda.gov.
 
The inspection resulted in FDA’s issuance of a Form FDA-483, Inspectional Observations, at the conclusion of the inspection.  We acknowledge your firm’s response received on June 26, 2017, which includes a description of the corrective actions taken by your firm.  We address the adequacy of your corrective actions below.
 
Pathogen Findings
FDA’s laboratory analysis of the May 24, 2017, environmental swabs found Salmonella in two separate subsamples collected from processing areas where food is likely to be exposed.  These locations include: 
  • (b)(4).  Salmonella Tennessee was isolated. 
  • (b)(4). Salmonella Johannesburg was isolated.  
Salmonella is a pathogenic organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.  Healthy individuals may suffer short-term symptoms such as severe diarrhea, bloody diarrhea, fever, chills, abdominal discomfort, and occasionally, vomiting. Therefore, appropriate control of Salmonella in a food processing environment is important.  It is essential to identify the areas of the food processing plant where this organism is able to grow and survive (niche areas) and to take such corrective actions as necessary to eradicate the organism by rendering these areas unable to support the growth and survival of the organism.
 
This was not the first time FDA investigators collected environmental samples from your facility that were found to be positive for Salmonella.  During a FDA inspection conducted May 24-26, 2016, FDA’s laboratory analysis isolated Salmonella senftenberg from an environmental swab collected from the (b)(4).  Additionally, during an FDA inspection conducted July 21-25, 2014, FDA’s laboratory analysis confirmed seven positive environmental samples identified as Salmonella species.  The seven positive environmental swabs were collected in the following locations:  (b)(4).
 
Record reviews conducted during our inspection revealed that Salmonella is frequently detected by your firm’s in-house environmental monitoring program. (b)(4) samples were positive between July 2016 - May 2017 (three of these samples were retests). With (b)(4) samples collected (b)(4) a month, the positive rate is approximately (b)(4)%. The areas (b)(4), have frequently tested positive for Salmonella.
 
FDA acknowledges your written response dated June 26, 2017, which states the two subsample locations that tested positive for Salmonella were cleaned and sanitized by your cleaning crew, and have been re-sampled with negative results. We are unable to verify the adequacy of your response because we have not received any documentation or evidence of the cleaning or testing, along with information on implementation of sanitary practices to ensure continued compliance. 
 
CGMP Violations
During the May 22 to June 12, 2017, inspection FDA investigators observed the following significant violations of the CGMP regulation for foods (21 CFR Part 110).
 
1.    Your plant is not constructed in such a manner that floors, walls, and ceilings may be adequately cleaned and kept clean and in good repair, and that drip and condensate from fixtures, ducts and pipes does not contaminate food, food-contact surfaces, or food-packaging materials, as required by 21 CFR 110.20(b)(4). Specifically, water leaks were noted in the following areas of your facility:
  • At least five areas throughout the vacated aseptic production and packaging area had water lines or steam lines that were actively dripping, creating puddles and causing damage to the floors. 
  • A cold-water line in the (b)(4) Dust Collection room was actively dripping on the floor next to an incoming air filter.
  • Rain was actively dripping through an external air filter housing unit on the second floor. The filter housing unit was adjacent to an unused ingredient elevator shaft near the second floor bagging bins.
Introduction of moisture into processing areas used to manufacture low moisture foods is a potentially serious concern as it can allow for the proliferation of any Salmonella present in the processing environment. Leaking in unused areas is a concern as well. Salmonella can contaminate and proliferate in these areas, particularly if they are not on a regular cleaning and sanitation schedule.  Traffic from employees, pests, equipment, etc., can then transfer Salmonella to other areas of the facility, such as production areas.
 
Your response stated that all inactive steam lines and traps were turned off in the second floor processing area, the access panel was sealed, the cold water line on the (b)(4) was turned off, the dehumidification equipment was removed, and louvers on the second floor external air filter were sealed in a closed position. Your firm’s response also stated that all areas with water or condensation were wet cleaned with detergent and sanitized as recommended by your current chemical provider. We will verify the adequacy of your corrective actions during our next inspection.
 
2.    Your firm failed to take all reasonable precautions to ensure that production procedures do not contribute contamination from any source, as required by 21 CFR 110.80. Specifically:
  • Water was observed on the 160, 145, and 130 levels and the ground floor of the spray dryer department.  
During the inspection it was noted that the cleaning and sanitation standard operating procedures (SOPs) lacked sufficient instruction to be conducted properly. For example, the “Drying Department Hot Bed and Cold Dryer” SOP lacks detail on how to prepare the sanitizer and how to verify the correct concentration is achieved. It also lacks detail on time and temperature application. In addition, documentation of cleaning was incomplete.
 
Water was observed on the 160, 145, and 130 levels and the ground floor of the spray dryer department. Introduction of moisture into processing areas used to manufacture low moisture foods is a potentially serious concern as it can allow for the proliferation of any Salmonella that might be present in the processing environment. This could ultimately lead to contamination of the finished product.
 
Your firm’s response states that your cleaning and sanitizing procedures will be reviewed by management and your chemical provider to include how cleaning is performed for each piece of equipment. The response further states that the sanitation practices will be added to sanitation checklists and reviewed by upper management.
 
However, your response did not include documentation that these corrections had been completed such as sanitation SOPs and/or checklists.  Nor did the response provide any timeframes for planned completion. We will verify the adequacy of your corrective actions during our next inspection.
 
3.    Your firm failed to hold food which can support the rapid growth of undesirable microorganisms at a temperature that prevents the food from becoming adulterated, as required by 21 CFR 110.80(b)(3). Specifically:
  • The temperature in the North Cooler was recorded between (b)(4)°F – (b)(4)°F for the last five months. 
  • (b)(4) lb. blocks of White Cheddar Cheese, wrapped in plastic and placed in wood crates, were stored in this cooler. The cheese appeared to be molding causing at least one crate to split apart. A black substance (identified as “whey” by Management) was running down the sides of the crates and pooling on the floor. 
  • Natural Enzyme Modified Cream labeled as “Keep Refrigerated” was stored in this cooler. 
Your response states that all product stored in the North Cooler was removed and destroyed on June 9, 2017. However, on June 12, 2017, FDA investigators noted that the product “Natural Enzyme Modified Cream” identified as “Keep Refrigerated” was still observed in the North Cooler with a temperature of 45ºF. Your response is inadequate, as you failed to address the issue that the temperature of the North Cooler is not being maintained at 45ºF to inhibit the growth of undesirable microorganisms. Failure to properly maintain an appropriate temperature could result in the food supporting the growth of pathogenic and/or spoilage microorganisms.
 
4.    Your firm failed to take precautions and restrictions when using insecticides to protect against the contamination of food, food-contact surfaces, and food-packaging materials and 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:
  • (b)(4) pallets of various dairy powders intended for animal food showed apparent beetle-like insects within the shrink wrap and on the exterior bags of product. During the inspection your firm’s management stated that the pallets were treated with a pesticide to contain the infestation. The pallets were treated within the second floor warehouse where pallets of powder intended for human and animal food were also held. There were no pest control records documenting when, how, or what treatment was applied. 
  • Crawling and flying insects were observed within the following areas of the facility:
Second and third floor Bagging Bin rooms
Robotic Palletizing room
Hot and Cold Fluid Bed Level 115
Dryer Level 145
(b)(4) Dust Collection room
Second floor warehouse
Vacated aseptic processing and packaging areas
 
Your firm’s response states that your Pest Control Officer was made aware of the situation and confirmed all pest control activities in the future will be recorded on the inspection report; however, no documentation was provided to confirm this correction.  In addition, you indicated that you have had an insect monitoring plan created for you by a pest control company which includes closing and sealing doors where activity is noted.  You also note that additional glue boards, insect light traps (ILTs), and pheromone traps have been added with further action to be taken if thresholds are exceeded. 
 
Your firm’s response further states that all product stored in this area was destroyed on June 9, 2017, and that FDA investigators verified this during the exit interview. However, on June 12, 2017, investigators observed (b)(4) new pallets of various dairy powders intended for use as animal feed with signs of active infestation with beetle-like insects, indicating that the insect problem was not addressed properly. We will verify the adequacy of your corrective actions during our next inspection.
 
5.    Your firm failed to provide safety type light bulbs, fixtures, or other glass suspended over exposed food in any step of preparation or otherwise protect against food contamination in case of glass breakage, as required by 21 CFR 110.20(b)(5). Specifically:
  • Pieces of a broken light shield were observed on the floor between pallets in the finished product warehouse near the Sapac Bagging room.  The light bulb above the pallets was exposed.
  • Pieces of a broken light shield were observed on the floor of the second floor warehouse near pallets of Varied Dairy Powder intended for Animal Feed. The light bulb was exposed. 
Your response states that the broken lights and light shields have been removed, cleaned and repaired, and that the exposed light bulbs have been covered, however, no documentation was provided to demonstrate the correction.
 
This letter is not intended to be all-inclusive and may not list all the violations at your facility. You are responsible for ensuring that you manufacture products in compliance with the Act and all of its implementing regulations, including the CGMP regulations (21 CFR Part 110). You are also responsible for using procedures to prevent further violations of the Act, all applicable regulations, and all other requirements of federal law.
 
You should take prompt action to correct the violations cited in this letter. Failure to do so may result in regulatory action being initiated by the FDA without further notice, including seizure of your products and/or enjoining your firm from operating.
 
You should notify this office in writing within 15 working days of receipt of this letter of any steps you have taken or will take to correct the noted violations and to prevent their recurrence. You should include with your response documentation of all corrective actions taken, any training logs, and any other information that would assist us in evaluating your 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. 
 
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 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 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 non-compliance 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 response to Compliance Officer Demetria L. Lueneburg at the address above. If you have questions regarding any issues in this letter, please contact Ms. Lueneburg at (612) 758-7210.
 
Sincerely,
/S/ 
Michael Dutcher, DVM
Director, Division 1 West
Office of Human and Animal Foods Operations
 
DLL/ccl
 
xc: David A. Cornelius
      Plant Manager
      Bluegrass Proteins, Inc.
      1864 311th Avenue
      Dawson, MN 56232-4216
 

[1] Part 110 was modernized and codified in Subpart B of Part 117 by the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (21 CFR 117) (PC rule). An establishment will continue to be subject to Part 110 until the Part 117 compliance date applicable to its business size. See http://www.fda.gov/Food/GuidanceRegulation/FSMA/ ucm334115.htm#Compliance_Datesfor PC rule compliance dates.