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WARNING LETTER

Coleman Peanut Company MARCS-CMS 520807 —


Recipient:
Coleman Peanut Company


United States

Issuing Office:
Baltimore District Office

United States


 

  

Black HHS-Blue FDA Logo

 

 

Baltimore District Office
6000 Metro Drive, Suite 101
Baltimore, MD 21215
Telephone: (410) 779-5455
 
 

 

WARNING LETTER
CMS# 520807
 
August 2, 2017
 
Via UPS
Signature Required
 
Mr. Lawrence L. Coleman, Owner
Coleman Peanut Company
17505 Parkdale Road
Petersburg, VA 23805
 
Dear Mr. Coleman:
 
The United States Food and Drug Administration (FDA or we) conducted an inspection of your facility located at 17505 Parkdale Road, Petersburg, VA 23805, November 29, 2016, through December 5, 2016. During the inspection, FDA found that your facility had 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) [1] Based on FDA’s inspectional findings documented during the inspection, we have determined that your manufactured and repackaged peanut products areadulterated 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 have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.   
 
Furthermore, during the inspection our investigator obtained labels that your firm uses for your VA Peanuts Salted (9 oz.); A Southern Tradition peanuts (22 oz.); Old Fashioned Peanut Candy (7 oz. and 9 oz.); and Butter Toffee Peanuts (8 oz.) products. Additionally, we reviewed your website at the Internet address www.epeanuts.com in May 2017 and have determined that you take orders there for your peanut products. Based on our review of your product labels and your website, we have concluded that your product labeling is in violation of the food labeling regulations, Title 21, Code of Federal Regulations, Part 101 (21 CFR Part 101), which causes your products to be misbranded within the meaning of Section 403 of the Act, [21 U.S.C. § 343]. You may find the Act, FDA’s regulations, CGMP regulations, and food labeling regulations through links in FDA’s home page at www.fda.gov.
 
Your significant violations are as follows:
 
Adulterated Food
 
1.    Your firm has not taken effective measures to exclude pests from the processing areas and protect against the contamination of food on the premises by pests, as required by 21 CFR 110.35(c). Specifically, during the current inspection, the following was observed:
  • A cat was observed in your plant being used as the firm’s pest control crawling atop permeable bags of in-shell peanuts.
  • Cat feces, R.E.P’s, and flying insects were observed in your processing plant and around packaged peanut products.
2.    Your firm has failed to manufacture and store foods under conditions and controls necessary to minimize contamination, as required by 21 CFR 110.80(b)(2). Specifically, during the current inspection, an opening along the bottom of the entire length of the plant where the sliding doors are located was observed exposing the interior of the firm to the outside environment.
 
3.    Employees at your firm did not wash hands thoroughly in an adequate hand-washing facility before starting work, as required by 21 CFR 110.10(b)(3). Specifically, during the current inspection, firm management was observed touching a cat and handling the trash into the firm’s dumpster. Firm management was then observed placing their bare hands into a sink where blanched, shelled, peanuts were waiting to be cooked in your plant without washing their hands.
 
4.    Employees at your firm were observed to be using tobacco in areas where food is exposed and equipment or utensils are washed, as required per 21 CFR 110.10(b)(8). Specifically, during the current inspection, cigarette butts in ashtrays were observed in two areas of your oil cooking plant near the 2-vat sink and near packaged peanut products.
 
5.    Your firm failed to conduct cleaning and sanitizing operations for utensils and equipment in a manner that protects against contamination of food and food-contact surfaces, as required per 21 CFR 110.35(a). Specifically, during the current inspection, your firm’s vent hood above the fryer, the fryer, the wall and 2-vat sink next to the fryer, the floor beside the fryer, and the hopper were observed to be insanitary with apparent food residue and discoloration on the surfaces.
 
6.    Your firm failed to properly store equipment that may constitute an attractant, breeding place, or harborage area for pests, within the immediate vicinity of the plant buildings or structures, as required per 21 CFR 110.20(a)(1). Specifically, during the current inspection, it was observed that old, unused equipment were being stored in multiple areas of your plant.
 
7.    Your firm failed to operate fans and other air-blowing equipment in a manner that minimizes the potential for contaminating food and food-contact surfaces, as required per 21 CFR 110.20(b)(6). Specifically, during the current inspection, the following was observed:
  • An accumulation of dust was observed on the blades of your industrial fan blowing on shelled peanuts.
  • An uncovered air conditioning vent with visible debris inside of it was observed located over exposed peanut products.
8.    Your firm’s employees failed to wear hair restraints where appropriate, as required per 21 CFR 110.10(b)(6). Specifically, during the current inspection, employees were observed manufacturing peanut products without wearing a hairnet.
 
Misbranded Food
 
9.    Your Coleman peanut products are misbranded within the meaning of Section 403(q) of the Act [21 U.S.C. § 343(q)] in that product labels fail to bear nutrition information (e.g., Nutrition Facts Panel) as required by 21 CFR 101.9. For example:
  • Your Old Fashioned Peanut Candy (7 oz and 9 oz), VA. Peanuts Unsalted/Salted (3 oz, 9 oz, 22 oz and 5 lb), Butter Toffee Peanuts (8 oz), and A Southern Tradition Peanuts (22 oz) labels fail to bear nutrition information (e.g. Nutrition Facts Panel) as required by 21 CFR 101.9. Your Coleman peanut products do not qualify for an exemption through the Small Business Nutrition Labeling Exemption program because there are nutrient content claims on the firm’s website and online catalog, which are considered labeling and must be in compliance with FDA’s labeling regulations.
  • Your Coleman peanut products fail to meet the requirements of 101.9(c)(7)(i) because protein claims are made on the labeling and the percentage of the RDI or DRV for protein, based on the  corrected amount of protein per serving and expressed as a Percent Daily Value is not provided. 
10.    Your Coleman peanut products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because they are fabricated from two or more ingredients, but the labels fail to bear a complete list of all the ingredients by common or usual name in descending order of predominance by weight as well as all sub-ingredients, as required by 21 CFR 101.4. For example,
  • Your VA. Peanuts Salted (3 oz and 9 oz), VA. Peanuts Unsalted (9 oz) and A Southern Tradition Peanuts (22 oz) product labels declare “Vegetable Oil;” which is not declared by the appropriate common or usual name as required by 21 CFR 101.4(b). In addition, the “vegetable oil” also contains sub-ingredients which must also be declared in accordance with 21 CFR 101.4(b).  
The requirement to list component ingredients (or “sub-ingredients”) may be met by either parenthetically listing the component ingredients after the common or usual name of the multi-component ingredient, or by listing the component ingredients without listing the multi-component ingredient itself. Under the first alternative, the component ingredients must be listed in descending order of predominance within the multi-component ingredient; and under the second alternative, the component ingredients must be listed in order of predominance in the finished food. 
 
11.    Your Old Fashioned Peanut Candy (7 oz), product is misbranded within the meaning of Section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] in that the place of business of the manufacturer is not declared as required in 21 CFR 101.5.
 
This letter is not an all-inclusive list of violations at your facility. It is your responsibility to ensure that your products comply with the Act and all applicable laws and regulations. You should take prompt action to correct the violations cited in this letter. Failure to do so may result in enforcement action without further notice, including, without limitation, seizure and injunction. 
 
In addition, we also offer the following comments regarding your labeling:
  • Your VA. Peanuts Salted (3 oz and 9 oz), VA. Peanuts Unsalted (9 oz), A Southern Tradition Peanuts (22 oz) do not include a street address.
  • Your Old Fashioned Peanut Candy (7 oz), A Southern Tradition Peanuts (22 oz), and Butter Toffee Peanuts (8 oz) contain a P.O. Box address, however, the use of a P.O. Box is not provided under 21 CFR 101.5 as an alternative to the street address.
  • Your Old Fashioned Peanut Candy (7 oz and 9 oz), Your VA. Peanuts Salted (3 oz and 9 oz), and VA. Peanuts Unsalted (9 oz) products may also provide the net quantity of contents in terms of the metric system as provided under 21 CFR 101.7(p).
  • We note that you include several nutrient content claims about protein on your product labeling. For example, page 7 of your product catalog http://colemanspeanutco.com/2012Catalog.pdf includes the claim, “peanuts are…[a]n outstanding source of protein.” FDA has not defined the term “outstanding source of protein;” however, under 21 CFR 101.54(b), the terms “high,” “rich in,” or “excellent source of” may be used to characterize the level of a nutrient on the label and in the labeling of foods provided that the food contains 20 percent or more of the Daily Reference Value (DRV) per reference amount customarily consumed (RACC). Furthermore, under 21 CFR 101.54(c), the terms “good source,” “contains,” or “provides” may be used on the label provided that the food contains 10 to 19 percent of the Reference Daily Intake (RDI) or Daily Reference Value (DRV) per RACC. Additionally, on your firm’s website, www.epeanuts.com, you state that “peanuts…are a good source of protein.” As protein is not declared on the VA Peanuts Salted (9 oz.); A Southern Tradition peanuts (22 oz.); Old Fashioned Peanut Candy (7 oz. and 9 oz.); and Butter Toffee Peanuts (8 oz.) product labels, it cannot be determined whether it is present at adequate levels to qualify for either of these claims. 
You should respond in writing within fifteen (15) working days from your receipt of this letter.  Your response should outline the specific things you have done or plan to do to correct these violations and prevent their recurrence.  You should include in your response documentation and other useful information that would assist us in evaluating your corrections.  If you cannot complete all corrections within 15 working days, you should explain the reason for your delay and the timeframe within which the remaining 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 noncompliance 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 noncompliance 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 reply to the U.S. Food and Drug Administration, Attention: CDR Rochelle B. Young, RPh, MSA, Compliance Officer, 6000 Metro Drive, Suite 101, Baltimore MD, 21215. If you have questions regarding any issues in this letter, please contact CDR Young by phone at 410-779-5437 or by email at rochelle.young@fda.hhs.gov.
 
 
Sincerely,
/S/                                                           
Evelyn Bonnin
Baltimore District Office
Program Division Director
Human and Animal Foods Division II East 


[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 Part 117) (CGMP & 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 CGMP & PC rule compliance dates.