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WARNING LETTER

K & B Company, Inc MARCS-CMS 528522 —


Recipient:
K & B Company, Inc


United States

Issuing Office:
Denver District Office

United States


 

  

Black HHS-Blue FDA Logo

 

Office of Human and Animal Foods - Division IV West
P.O. Box 25087
Denver, Colorado 80225-0087

 
 

 

July 5, 2017
 
WARNING LETTER
 
 
Via UPS Overnight
 
 
Brent A. Bischoff
President
K & B Company Inc.
109 Arnold St.
Gallup, NM 87301
 
 
Ref. No: HAF4W(DEN)-17-09-WL (DR)
 
 
Dear Mr. Bischoff:
 
Representatives of the Food and Drug Administration (FDA) conducted an inspection of your facility located at 109 Arnold St., Gallup, NM from May 08 - May 15, 2017. The inspection found that you have serious violations of FDA’s Current Good Manufacturing Practice (CGMP) in Manufacturing, Packing, or Holding Human Food, Title 21, Code of Federal Regulations (CFR) Part 110 (21 CFR 110). These conditions cause the bakery products produced 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 U.S.C.§ 342(a)(4)] in that your bakery products have been 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 the CGMP food regulations through links on the FDA’s homepage at http://www.fda.gov. A copy of the FDA-483, Inspectional Observations, issued to you at the close of our inspection, is attached with this letter for your convenience.
 
Violations revealed during the inspection include, but are not limited to, the following:
 
1.    Your firm failed to manufacture, package and store foods under conditions and controls necessary to minimize the potential for growth of microorganisms and contamination as required by 110.80(b)(2). Specifically:
 
a.  Your firm failed to minimize the growth of microorganisms (mold) and protect against contamination in the following areas:
 
i.  Walls, overhead door, and cooling fan in areas used to cool baked bread.
ii.  Condenser fans and support pole in walk-in refrigerator used to store uncovered apple pies.  
iii.  3-Compartment sink used to clean in process equipment.
 
b.  We observed peeling paint in the incoming supply room above ingredient containers which had broken lids, no lids, lids not fully covering materials. Additionally, peeling paint was observed on the ceiling of the walk-in refrigerator used to store uncovered apple pies.  
 
c.  We observed fresh and dried dough on the ceiling above an uncovered mixer and along the rim of the (b)(4) bucket. (b)(4) is used as a processing aid in the production of (b)(4)
 
            You were previously cited for these same or similar violations during the May 2014 inspection.
 
2.    Your plant is not constructed in such a manner as to prevent drip or condensate from contaminating food, food-contact surfaces and food-packaging materials as required by 110.20(b)(4). For example:
 
a.  Condensation buildup was observed inside the (b)(4)  proofing (b)(4)  along the ceiling, sides of walls, and along the door frame. As the uncovered dough enters the (b)(4)  proofing (b)(4), condensation drips directly onto uncovered dough.
 
b.  Dark brown condensation buildup was observed in the production area on the ceiling above the (b)(4)  proofing (b)(4)  and the final bread rolling area.
 
c.  Condensation buildup was observed in the walk-in freezer fans located above finished product.
 
3.    Your firm failed to provide adequate screening or other protection against pests as required by 21 CFR 110.20(b)(7). Specifically, the outer door and warehouse garage doors were open during food production activities without adequate protection to prevent entry of pests into the production facility.
 
You were previously cited for these same or similar violations during the October 2010 and May 2014 inspections.
 
4.    Personnel responsible for identifying sanitation failures and food contamination lack a background of education and experience to provide a needed level of competency as required by 21 CFR 110.10(c). Specifically:
 
a.  The production manager did not know the correct order of operation to properly clean and sanitize utensils at the 3-compartment sink. The 3-compartrnent sink was set up in the following incorrect order: wash, sanitize, and rinse. During the inspection, the rinse water was observed to be cloudy and dirty, providing a possible source of cross-contamination.
 
b.  The production manager did not know what the adequate sanitizer concentration should be; there were no test strips available to verify the concentration, and he relied solely on placing one capful of bleach into water.
 
c.  The president of the company lacks basic sanitation knowledge. For example, when asked about the sanitation procedures, he commented on cleaning the floors and was not aware of equipment cleaning and maintenance schedules. He also did not know the required sanitizer concentration and did not provide test strips to employees for verification.
 
5.    Your firm failed to provide appropriate training in food handling techniques and food protection principles have not been provided to food handlers as required by 21 CFR 110.10(c). Specifically:
 
a.  Our investigator observed an employee touching ready to eat bread rolls with bare hands to determine if they were cool enough for packaging.
 
b.  Our investigator observed an employee in the packaging area wearing only one glove, on the right hand. The employee was manually sorting bread into final packaging with both the gloved and bare hands.
 
You were previously cited for these same or similar violations during the May 2014 inspection.
 
6.    The procedure used for cleaning and sanitizing of equipment and utensils has not been shown to provide adequate cleaning and sanitizing treatment as required by 21 CFR 110.35(d)(5). Specifically:
 
a.  The 3-compartrnent sink was set up in the following incorrect order: wash, sanitize, and rinse. Utensils were then immediately used without allowing them to air dry.
 
b.  At the final dough (b)(4), recently used trays covered with residue were slammed on the floor to remove particles and then placed onto the cart, without washing, to be reused. Our investigator observed fresh dough immediately placed on these trays and sent to the (b)(4)  proofing (b)(4).
 
c.  In the (b)(4)  proof (b)(4), there is no evidence that the conveyor trays used to transport the dough from the extruder to the (b)(4) are sanitized.
 
d.  Your firm’s water filters have not been changed since 2013. Our investigator observed dark brown and slimy residue in the filter. The filtered water is used in the production of dough, to clean large pieces of equipment, and used in the 3-compartment sink.
 
The above violations are not intended to be an all-inclusive statement of violations that exist in your facility. You have been cited for many of these items several times before, but you have taken no corrective action in response to those citations. You are responsible for investigating and determining the causes of the violations identified above and for preventing the recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all applicable requirements of federal law, the Act, and its implementing regulations. You should take prompt action to correct violations cited in this letter and establish procedures to ensure such violations do not recur. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and/or injunction. 
 
Within fifteen (15) business days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct the violations noted above. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of supporting documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. 
 
Address your reply to the U.S. Food and Drug Administration; Attn: Caroline H. Le, Compliance Officer and Nancy G. Schmidt, Compliance Officer; P.O. Box 25087, Denver, Colorado, 80225-0087. You may reach Dr. Le at (303) 236-3045 if you have any questions about this matter.
 
Sincerely,
/S/ 
LaTonya M. Mitchell
District Director, FDA Denver District
Program Division Director
Office of Human and Animal Foods – Division IV West