Inspections, Compliance, Enforcement, and Criminal Investigations
Meherrin Agricultural & Chemical Co. 3/23/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Atlanta District Office
March 23, 2012
Garland Dallas Barnes, President/CEO
Meherrin Agricultural & Chemical Co.
413 Main Street
Severn, NC 27877
Dear Mr. Barnes:
On November 15 - December 6, 2011, U.S. Food and Drug Administration (FDA) investigators inspected your peanut butter processing plant, Hampton Farms Industrial Plant, located at 101 Vircar Street in Severn, NC. The establishment inspection revealed 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 cause your peanut butter products to be adulterated with the meaning of Section 402(a)(4) of the Act [21 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 the general food regulation through links on FDA's homepage at www.fda.gov.
Your significant food CGMP violations include the following observations:
1. The design, construction, and use of equipment and utensils shall preclude the adulteration of food with lubricants, fuel, metal fragments, contaminated water, or any other contaminants to comply with 21 CFR 110.40(a). Your firm purchased a band saw and used it to cut the bottoms off customer-returned 18 oz. plastic jars of peanut butter. The peanut butter from some of these jars was subsequently reworked into new product, at a post-kill step, and was distributed in interstate commerce. Your use of a band saw and your storage practices exposed the product to potential extraneous material and contamination.
We acknowledge that on November 23, 2011, your firm voluntarily recalled specific lots of peanut butter product that had been reworked in this manner.
2. To comply with 21 CFR 110.80(a)(5), you must hold raw materials, other ingredients, and rework in bulk or in containers designed and constructed so as to protect against contamination and shall be held in such a manner as to prevent the food from becoming adulterated within the meaning of the Act. In addition, materials scheduled for rework must be identified as such.
However, (b)(4) approximately (b)(4) pound barrels, containing 18 oz. jars of peanut butter with the bottoms cut off, were stored in your finished product warehouse while the jars of product were awaiting rework. The peanut butter in these jars was exposed and leaking out causing the product to come in direct contact with the outside of the other containers. The aforementioned product, in addition to (b)(4) pallets of returned finished product peanut butter in 12/18oz cases, identified by your employees as pending rework, were not labeled or otherwise identified as product for rework.
We acknowledge that on December 6, 2011, you destroyed the (b)(4) approximately (b)(4) pound barrels, containing 10 oz. jars of peanut butter product intended for rework, that were under embargo by the North Carolina Department of Agriculture and Consumer Services.
3. Your plant and facilities must permit the taking of proper precautions to reduce the potential for contamination of food, food-contact surfaces, or food-packaging materials with microorganisms, chemicals, filth, or other extraneous materials, to comply with 21 CFR 110.20(b)(2). However, our investigators observed the following:
• On 11/13/11, the (b)(4) filler hopper was observed to be open to the production room environment. A black hose was observed to continually hit the side. of this open filler hopper, potentially allowing contaminants to enter the hopper from the outside of the hose. There is also a walkway directly above this open hopper that is used by employees accessing the ingredient platform and votators.
• On 11/16/11, soiled cardboard was observed to be used to cover the soiled floor of the mezzanine above the (b)(4) grinders potentially allowing contaminants falling from mezzanine to enter the finished product bulk container filling stations and open filler hopper.
• Condensation was observed throughout the inspection continually dripping from the votator onto the mezzanine walkway located directly above the (b)(4) filler and (b)(4) grinders. This condensate could potentially drip into the open filler or open bulk containers being filled leading to a direct product contamination.
4. You must perform filling, assembling, packaging, and other operations in such a way that the food is protected against contamination, to comply with 21 CFR 110.80(b)(13). However, our investigators observed the following:
• During the period of 11/15-17/11, the access door from the finished product processing area to the raw peanut end of the roaster was observed to be open approximately one to three inches, potentially exposing the finished processing environment and machinery to raw (unprocessed) peanut dust and small flying debris.
• On 11/16/11, a gloved employee was observed to open a bag of sugar with a knife containing a soiled handle, add the sugar to the peanut butter ingredient hopper, adjust the trash liner, then scratch his face, and return to add more sugar to the line without washing hands or replacing gloves.
• On 11/16/11, a gloved employee was observed to. clean up peanut butter from the floor which had dripped from grinder one onto the production floor and then return to the filling line without washing hands or replacing gloves.
5. You must take effective measures to exclude pests from the processing areas and to protect against the contamination of food on the premises by pests, to comply with 21 CFR 110.35(c).
However, our investigators observed the following:
• On 11/15-16/11 in your peanut processing areas, flies (greater than 10) were observed landing on employees, rework canisters, equipment, and investigators.
• A 1/2- 3/4 inch gap around the compressor line, which leads from the processing room to the outside, was observed.
6. You must ensure that the floors, walls, and ceilings are constructed in such a manner that they may be cleaned adequately and kept clean and in good repair, to comply with 21 CFR 110.20(b)(4). However, our investigators observed the following:
• Your plant has a concrete repair in front of the blancher room that is approximately 8 inches wide and runs from the east to west wall that was observed to be rough and retaining dark colored water when one of the loose patches of concrete was moved.
• On 11/17/11, an approximate 1.5 x 2.5 foot patch of pooling water was observed seeping into the production room from under the closed rollup overhead door on the west wall.
• A black viscous substance was observed throughout the inspection to be dripping continually onto the floor from the exhaust duct which is connected from the roaster to the west wall.
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, but not limited to, seizure of your products or injunction.
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 the current violations and prevent similar ones. Include the timeframe within which the corrections 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
FDA 483, Inspectional Observations form
Daniel L. Hutton, Vice President of Operations
Hampton Farms Industrial Plant
101 Vircar Street
Severn, NC 27877