Inspections, Compliance, Enforcement, and Criminal Investigations
Sugar Plum Foods 8/18/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|New Orleans District|
404 BNA Drive
Suite 500 Building 200
Nashville, TN 37217
August 18, 2011
Warning Letter no. 2011-NOL-21
United Parcel Service
Delivery Signature Requested
Harold T. (Tim) Sprecher, Co-Owner
Doris E. Sprecher, Co-Owner
Sugar Plum Foods
2404 Highway 31 W South
White House, Tennessee 37188
Dear Mr. and Mrs. Sprecher:
The U.S. Food and Drug Administration (FDA) inspected your acidified food facility, located at 2404 Highway 31 W South, White House, Tennessee, on May 17-20, 2011. During the inspection, FDA investigators documented serious violations of Title 21, Code of Federal Regulations, Parts 108 (21 CFR 108), Emergency Permit Control; 114, Acidified Foods; and, 110, Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food. The inspection revealed your acidified foods to be adulterated under Section 402(a)(4) [21 United States Code (USC) 342(a)(4)] of the Federal Food, Drug, and Cosmetic Act (the Act) because they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You can find the Act and the regulations through links in FDA’s Internet home page at www.fda.gov.
This inspection resulted in FDA’s issuance of a Form FDA 483, Inspectional Observations, to Doris E. Sprecher on May 20, 2011, which included the following deviations:
1. Failure to provide the FDA, before packing any new product, information on the scheduled processes for each acidified food in each container size [21 CFR 108.25(c)(2)]. Your firm has not filed scheduled processes with FDA for your Chow Chow Relish and Pickled Beets products.
2. Failure to have personnel involved in acidification, pH control, and critical factors under the operating supervision of a person who has attended and satisfactorily completed a school approved by the Commissioner [21 CFR 108.25(f)]. The one person who is trained is not supervising the acidified food manufacturing operations.
3. Failure to exercise sufficient control including frequent testing to ensure the finished equilibrium pH values are not higher than 4.6 [21 CFR 114.80(a)(2)]. Your firm does not frequently test the pH of the Chow Chow Relish product. No homogenous mix is prepared and used for the pH testing. Additional information concerning methodology for use in determining product pH can be found at 21 CFR 114.90.
4. Failure to identify each container of acidified food with an identifying code specifying the year and date [21 CFR 114.80(b)]. No year and date code is identified on acidified products manufactured for private label customers.
5. Failure to prepare and maintain in files current procedures for recalling products which may be injurious to health, notifying FDA, and implementing recall programs [21 CFR 108.25(e)]. Your firm had no recall procedure on file.
This letter is not intended to be an all inclusive review of your manufacturing practices. It is your responsibility to ensure all products marketed by your firm comply with the Act and the applicable regulations. You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure and injunction.
Additional observations included failure to take necessary precautions to protect against contamination of food and food packaging systems with foreign substances [21 CFR 110.10(b)(9)]. Poor employee sanitation practices were observed during the inspection. These included failure to wash and sanitizing hands after contacting potential sources of contamination; use of hair coverings that were inadequate; and wearing of soiled tee shirts and aprons.
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Your response should be sent to U.S. Food and Drug Administration, Attention: Kari L. Batey at the above address. If you have any questions about the content of this letter, please contact Ms. Batey at (615) 366-7808.
Thomas D. Clarida
Acting District Director
New Orleans District