Stanley C. Bracey
- B & H Foods Inc
2122 Thrift Road
Charlotte, NC 28208
- Issuing Office:
- Atlanta District Office
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Atlanta District Office
60 Eighth Street N.E.
Atlanta, GA 30309
November 14, 2017
VIA UNITED PARCEL SERVICE
NEXT DAY - SIGNATURE REQUIRED
Stanley C. Bracey, President
Bill R. Rudisill, General Manager
2122 Thrift Road
Charlotte, NC 28208
Dear Mr. Bracey:
The United States Food & Drug Administration (FDA) inspected your refrigerated ready-to-eat (RTE) salad manufacturing facility located at 2122 Thrift Road, Charlotte, NC 28208 from May 9 through 31, 2017. During our inspection, FDA collected environmental samples (i.e., swabs) from various areas in your processing facility, including areas that are near food and food contact surfaces. FDA laboratory analyses of the environmental swabs found the presence of Listeria monocytogenes (L. monocytogenes), a human pathogen in your facility. Additionally, FDA investigators observed serious violations of the Current Good Manufacturing Practice (CGMP) in Manufacturing, Packing, or Holding Human Food regulation, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110) 
. Based on FDA’s analytical results for the environmental sample and inspectional findings documented during the inspection, we have determined that your RTE 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 were prepared, packed or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act and FDA's regulations through links in FDA's home page at http://www.fda.gov
The inspection resulted in FDA’s issuance of a FDA-Form 483, Inspectional Observations, at the conclusion of the inspection. We acknowledge your firm’s written responses dated June 5, 2017, June 17, 2017, June 21, 2017 and July 20, 2017, which include a description of the corrective actions taken by your firm. We address the adequacy of your corrective actions below.
L. monocytogenes is a pathogenic bacterium that is widespread in the environment and may be introduced into a food processing facility from raw materials, humans or equipment. Without proper controls, it can proliferate in food processing facilities where it may contaminate food. Therefore, it is essential to identify the areas of the food processing plant where this organism can grow and survive and to take such corrective actions as necessary to eradicate the organism. Consuming foods contaminated with L. monocytogenes can lead to a severe, sometimes life-threatening illness called listeriosis, a foodborne illness, which is a major public health concern due to the severity of the disease, its high case-fatality rate, its long incubation time, and its tendency to affect individuals with underlying conditions.
FDA laboratory analysis of the environmental sample collected May 9, 2017, confirmed that two (2) environmental swabs were positive for L. monocytogenes. The two swabs were collected from the manufacturing area in the following locations:
- One (1) collected from the wheel of (b)(4) that was supported by a stack of lids located in the back kitchen. The lids contained accumulated water and debris and were continuously leaking product at connection junctions.
- One (1) collected from the (b)(4) under the packer in the back kitchen. Potato salad was being manufactured in the back kitchen during the inspection.
Whole Genome Sequencing (WGS) analysis was conducted on the two (2) L. monocytogenes isolates obtained from the FDA environmental sample collected on May 9, 2017 during the inspection of your Charlotte, NC facility. WGS of food-borne pathogens provides high-resolution data, enabling direct links to be established between clinical isolates and food or environmental sources of bacterial contamination and illness. WGS data can also be used to infer the evolutionary relationships (or phylogeny) within a given set of isolates as it measures each DNA sequence in a bacterial genome.
The WGS phylogenetic analysis found that there are 2 strains of L. monocytogenes present in your facility. Of the 2 strains:
- One environmental swab (INV999610-139) isolated one strain of L. monocytogenes. Comparing this strain to the larger WGS database shows that it is identical to (b)(4) FDA environmental swabs collected from your Chester, SC facility in May 2012, August 2013, and April 2015. This strain was also found in (b)(4) isolates that were obtained from USDA samples of chicken salad and ham salad from your Charlotte, NC facility, and (b)(4) of USDA’s environmental swabs collected from your Charlotte, NC facility in 2015. This evidence demonstrates that L. monocytogenes has maintained a presence in your Chester, South Carolina facility from 2012-2015 and an identical strain of L. monocytogenes has been isolated in your Charlotte, NC processing environment.
- One environmental swab (INV999610-140) isolated the second strain of L. monocytogenes. Comparing this strain to the larger WGS database shows that it is identical to L. monocytogenes isolated from FDA’s February 2017 sample of your Chester, SC facility’s pimento spread, the state of North Carolina’s 2017 sample of your pimento cheese and old fashioned spread, and FDA environmental swabs collected from your Chester, SC facility in May 2012, August 2013 and April 2015. This evidence demonstrates that L. monocytogenes had maintained a presence in your Chester, South Carolina facility from 2012-2017 and an identical strain of L. monocytogenes has been isolated in your Charlotte, NC processing environment.
The presence of L. monocytogenes in your facility is significant in that they demonstrate your cleaning and sanitation practices are inadequate to effectively control pathogens in your facility to prevent contamination of food. Furthermore, L. monocytogenes found in the environment of your facility increases the risk of your finished product becoming contaminated. Once established in a production area, personnel or equipment can facilitate the pathogen’s movement and contamination of food-contact surfaces and finished product. It is essential to identify the areas of the food processing plant where this organism can grow and survive and to take necessary corrective actions to eradicate the organism.
Additionally, FDA investigators observed the following significant violations of the Current Good Manufacturing Practice regulation for foods:
1. You 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 21 CFR Part 110.80(b)(2). For example:
a. The production sprayers and the water bath hose were observed pooling water throughout the entire production room floor and splashing water onto food contact surfaces including tables as well as on raw ingredients while pimento spread was being made.
b. Investigators observed the soiled garments of employees including hair nets, arm guards, and aprons coming into direct contact with raw ingredients and in-process finished product. Further, an employee was observed using a probe thermometer to check the temperature of each batch of pimento spread without cleaning or sanitizing it between uses. The employee stored the thermometer in a container of room temperature water that was observed to contain product debris.
c. Investigators observed multiple instances of employees storing and resting food contact equipment such as product scoops and spatulas on non-food contact surfaces such as brown paper towels and tables then using them to manipulate raw materials and/or in process finished product without first washing or sanitizing them.
d. After sanitation operations, had been completed in the back kitchen a mixer had chicken salad residue and dried mayo debris on the paddle, the interior and the mixer stand attachment. The equipment was used for the next production run without any additional sanitation being performed.
e. Investigators observed a bucket labeled as sweet pickle relish to contain bleach, a bucket labeled as diced celery to contain quaternary ammonia, and an unidentified container, which reportedly contained bleach, was found to contain a 50ppm chlorine solution. Throughout the inspection these chemicals were observed to be stored directly adjacent to the potato washer and the potato conveyor where food items were actively undergoing processing. In addition, the investigators observed sanitizer overspray to be inside an open box containing finished product containers as well as wetting boxes containing finished product container.
We acknowledge your written responses dated June 5, 2017, June 17, 2017, June 21, 2017 and July 20, 2017; however, we cannot evaluate the adequacy of your corrective actions because you have not provided any documentation. While you indicate that you have completed a full teardown of the equipment and cleaned and sanitized, cleaning and sanitizing alone does not fully address the observations especially the underlying employee practices that contributed to the observations. Your initial response states that you planned to have an employee meeting later that day, followed by a weekly meeting. Your subsequent responses, dated June 17, 2017, June 21, 2017 and July 20, 2017, do not demonstrate that these meetings occurred or what topics were covered. We will evaluate your corrective actions during a future inspection.
2. You failed to ensure all equipment, containers, and utensils are constructed, handled, and maintained during manufacturing or storage in a manner protecting against contamination as required by 21 CFR Part 110.80(b)(7)]. For example:
a. Food contact surfaces such as mixers, finished product troughs, raw ingredient transport bowls, cutting boards, and salad tubs were not maintained in a condition such that they could be properly cleaned and sanitized and may become harborage site for pathogens. Finished product troughs, raw ingredient transport bowls, and mixers were observed to be pitted and cracked, cutting boards contained numerous gauges and cuts and salad tubs were heavily gouged.
b. The plastic conveyor belt sections and paddles were observed missing and broken on the elevated potato washer conveyor.
Further, two pallets of canned pimentos and one pallet of canned jalapenos were observed to be stored in the maintenance shop. The pallet of jalapenos had opened motor oil containers and lubricants stored on top. The front pallet of pimento had a viscous black liquid spilled onto the middle cans on the pallet. Chemical drums stored adjacent to the rear kitchen were observed to be leaking onto open boxes of finished product containers.
We acknowledge your written responses dated June 5, 2017, June 17, 2017, June 21, 2017 and July 20, 2017; however, we cannot evaluate the adequacy of your corrective actions because you have not provided any documentation. While you indicate that you have completed a full teardown of the equipment and cleaned and sanitized, cleaning and sanitizing alone does not fully address the observations especially the underlying employee practices that contributed to the observations. Your initial response states that you planned to have an employee meeting later that day, followed by a weekly meeting. Your subsequent responses, dated June 17, 2017, June 21, 2017 and July 20, 2017, do not demonstrate that these meetings occurred or what topics were covered. You also failed to address the equipment and utensils that appeared to be gouged or cracked. Gouges, pits and cracks in the equipment and utensils can become harborage site for pathogens and are difficult to properly clean and sanitize. We will evaluate your corrective actions during a future inspection.
3. Your facility 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 or condensate from fixtures, ducts and pipes does not contaminate food, food-contact surfaces, or food-packaging materials as required by 21 CFR Part 110.20(b)(4). For example:
a. During the inspection condensate was observed dripping onto packaged product, exposed raw materials such as relish and cabbage, and food contact surfaces. Condensate was also observed pooling where sanitized production equipment was being stored.
b. Accumulated condensation from a shop fan in the front and was blowing onto sanitized cooked potato containers.
c. A leaking pressure valve above the ceiling in the front kitchen was observed to be causing a ceiling leak.
d. The floors and walls in the front and back kitchens have multiple areas where the coating is chipping up and where holes were inadequately repaired and resealed. Areas of reinforcement in walk-in cooler #1 and #2 along the walls were observed to be broken and in disrepair.
We acknowledge your written responses dated June 5, 2017, June 17, 2017, June 21, 2017 and July 20, 2017; however, we cannot evaluate the adequacy of your corrective actions. You state that employees have been warned to look out for condensate and that you have ordered a pressure valve to correct the issue. However, you failed to address the condensate that was observed in coolers #2, #3, and #4, as well as onto the processing table. In addition, you have not submitted any documentation (i.e. purchase orders, copies of standard operating procedures, or photographs) to support that the valve has been purchased and installed. Your corrective actions will be evaluated during the next FDA inspection.
4. You failed to ensure all personnel working in direct contact with food, food contact surfaces, and food packaging materials conform to hygienic practices while on duty to the extent necessary to protect against contamination of food as required by 21 CFR Part 110.10(b). For example:
a. Employees failed to maintain gloves used in food handling in an intact, clean, and sanitary condition as required by 21 CFR Part 110.10(b)(5). For example, an employee in the front kitchen was observed using gloved hands to assemble sanitized production equipment. This employee stopped assembly to manipulate the hose that had been on the floor and then resumed assembling the sanitized equipment without first washing and sanitizing or changing the gloves.
b. Employees did not wash hands thoroughly in an adequate hand-washing facility at any time their hands may have become soiled or contaminated as required by 21 CFR Part 110.10(b)(3). For example:
i. Multiple employees were observed returning from breaks without washing their hands or washed their hands and then put on hairnets and earphones, without first re-washing their hands, before resuming production activities in the front and back kitchens and the spice room.
ii. Throughout the inspection the front and back kitchen mixer employees were observed touching non-food contact surfaces such as shovels, buttons, equipment, buckets, cardboard boxes, waste bins, drums, kettles, and tables with gloved hands, then using the same gloved hands, without first sanitizing or changing, to handle raw ingredients and subsequently handle finished product and food contact surfaces.
iii. A production employee was observed after a break in production to come directly from the break area into the spice room, handle non-food contact surfaces including a door handle, tables, a screw driver and then handle food production equipment such as a mixer, paddle, and a hose without first washing or sanitizing their hands.
iv. Employees were observed entering the front kitchen production room from the spice room, handling non-food contact equipment such as a radio, boxes, and a trash can and then not washing or sanitizing their hands before performing work that included their bare hands touching the interior of “(b)(4)” finished product containers.
Further, the hand washing station at the back kitchen lacked hand towels and the hand towel dispenser was non-operational.
We acknowledge your written responses dated June 5, 2017, June 17, 2017, June 21, 2017 and July 20, 2017. We cannot evaluate the adequacy of your corrective actions because you have not provided any documentation. Your initial response states that you planned to have an employee meeting later that day followed by a weekly meeting. Your subsequent responses, dated June 17, 2017, June 21, 2017 and July 20, 2017, do not demonstrate that these meetings occurred or what topics were covered. We will evaluate your corrective actions during a future inspection.
5. Your plumbing constitutes a source of contamination to food, equipment, and utensils per 21 CFR Part 110.37 (b)(3). The equipment washing sink in the front kitchen was observed to be directly plumbed into the sewer system without an air break or a backflow prevention device.
We acknowledge your written responses dated June 5, 2017, June 17, 2017, June 21, 2017 and July 20, 2017. We cannot evaluate the adequacy of your corrective actions because you have not provided any documentation. You indicate that you would have a plumber come into the facility in the next week to fix the issues with the plumbing; however, you fail to address this in any of your subsequent responses that were dated June 17, 2017, June 21, 2017 and July 20, 2017. We will evaluate your corrective actions during a future inspection.
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist at your facility. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to assure that you comply with all requirements of federal law and FDA regulations. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.
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 determining 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.
You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. 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 fifteen (15) working days of receiving this letter, 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 Janice L. King, Compliance Officer, U.S. Food and Drug Administration, 4600 Goer Drive, #106, North Charleston, SC 29406. If you have any questions about this letter, please contact Compliance Officer King at (843) 746-2990 x16 or via email at email@example.com.
Ingrid A. Zambrana
U.S. Food & Drug Adminisration
FDA Atlanta District
Office of Human and Animal Foods- Division 3 East
(Georgia- North Carolina-South Carolina)
Office of Regulatory Affairs
 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 Part 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_Dates for PC rule compliance dates.