Inspections, Compliance, Enforcement, and Criminal Investigations
B & H Foods Inc 10/17/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Atlanta District Office
60 Eighth Street N.E.
Atlanta, GA 30309
October 17, 2012
Stanley C. Bracey, President
Bill Rudisill, General Manager
B & H Foods, Inc.
2122 Thrift Road
Charlotte, NC 29266-8568
Dear Mr. Bracey and Mr. Rudisill:
On May 21-23, 2012, investigators of the U.S. Food and Drug Administration (FDA) conducted an inspection of your pimento cheese processing facility, located at 181 Saluda Street in Chester, SC. During the inspection, FDA investigators observed serious violations of the Current Good Manufacturing Practice (CGMP) regulation for foods, found in Title 21 of the Code of Federal Regulations Part 110 (21 CFR 110). These violations render the pimento cheese products manufactured in your facility adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetics Act (the Act) [21 United States Code (U.S.C.) § 342(a)(4)], in that the products were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. You may find the Act and pertinent FDA regulations through links on FDA’s website at www.fda.gov.
Your serious violations of the CGMP regulation for foods are as follows:
- You must maintain buildings, fixtures, and other physical facilities of the plant in a sanitary condition and keep them in repair sufficient to prevent food from becoming adulterated, to comply with 21 CFR 110.35(a). However, the floor in the production room was observed to be pitted, cracked, and unsealed. Stagnant water was also observed inside the main walk-in refrigerator on the left and right sides of the door, underneath and adjacent to the doorway ramp inside the storage room leading into the production room, and inside the inadequately sealed boiler drains located in the production room.
Your response received on June 13, 2012, states that cracks on the floor of the production room were sealed; however, you failed to address the standing water or to provide documentation of your corrective actions. For example, providing photographs could help demonstrate whether the corrective actions occurred and were adequate.
- You must provide, where necessary, adequate screening or other protection against pests, to comply with 21 CFR 110.20(b)(7). However, the metal roll-up door used in the removal of waste from the facility was observed with a gap underneath that was approximately ½” – 1” high by 12” long, allowing for the potential entry of pests, such as rodents and insects.
Your response to this observation states that the door was repaired; however, you failed to provide documentation of your corrective actions. For example, providing photographs help demonstrate whether the corrective actions occurred and were adequate.
This letter is not intended to be an all-inclusive statement of the violations that exist at your firm. You are responsible for ensuring that your firm is operating in compliance with all the requirements of the Act and pertinent FDA regulations. You should take prompt actions to correct the violations cited in this letter. Failure to promptly and adequately correct these violations may result in FDA initiation of regulatory actions including, but not limited to, seizure of your products or injunction.
In addition to the above violations, we have the following comment:
During the inspection environmental samples were collected throughout your facility. A total of 14 locations within your facility tested positive for L. monocytogenes. Two of these locations are considered Zone 1 (food contact surface) locations: the left band of the cheese cutter and the outer rim of the cheese mixer on line B.
We note that although your finished product pimento cheese spread may not support the growth of L. monocytogenes, the positive environmental swabs are indicators of insanitary conditions in your facility and demonstrate the failure of cleaning and sanitation operations which may allow for contamination of foods with filth or pathogens. Moreover, an employee was observed using a spatula to scrape the excess cheese mixture from the outside of the cheese mixer on line B (a location that yielded a positive finding for L. monocytogenes) and adding it to the product in the trough holding tank. We acknowledge that you addressed the unacceptable employee practice through additional training to the employee, but we recommend that you also take steps to address the environmental findings in your facility.
Please be advised that FDA has issued draft guidance entitled Guidance for Industry: Control of Listeria monocytogenes in Refrigerated or Frozen Ready-To-Eat Foods; Draft Guidance. You may submit comments on this draft guidance to the agency as outlined in the document. The draft guidance is available online at: http://www.fda.gov/food/guidancecomplianceregulatoryinformation/guidancedocuments/foodprocessinghaccp/ucm073110.htm.
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 reinspection-related costs. A reinspection 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. Reinspection-related costs means all expenses, including administrative expenses incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees [21 U.S.C. 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for reinspection-related costs from the responsible party for the domestic facility.
Please respond to this office in writing within fifteen (15) working days from your receipt of this letter. In your response, identify the steps you have taken or plan to take to correct these current violations and to prevent future violations. Include the timeframe within which the corrective actions will be completed and documentation that will effectively assist us in evaluating the adequacy of the corrections. If you are unable to complete the corrective actions within fifteen (15) working days, identify the reason for the delay and the timeframe within which you will complete the corrections.
Your written response should be sent to the U.S. Food and Drug Administration, Attn: Lakisha N. Morton, Compliance Officer, at the address noted in the letterhead. If you have any questions, please contact Mrs. Morton at 404-253-1285 or write her at the noted address.
John R. Gridley
Atlanta District Office
Bill Rudisill, General Manager
B&H Foods, Inc.
181 Saluda Street
Chester, SC 29706