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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Woeber Mustard Manufacturing Co Inc 12/13/11

  

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 Cincinnati District Office
Central Region
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-2761
 

Warning Letter
CIN-12-230394-06

December 13, 2011

United Parcel Services
Mr. Richard Woeber, Owner
Woeber Mustard Manufacturing Co Inc
PO Box 388
Springfield, Ohio 45501-0388

Dear Mr. Woeber:

We inspected your processing facility, located at 1966 Commerce Circle, Springfield, Ohio 45501 on August 10, 11, 16, 17, 24 and September 12, 2011. We found that you have serious violations of the juice Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 120 (21 CFR Part 120) and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 120 & 110). In accordance with 21 CFR 120.9, failure of a processor of juice products to have and implement a HACCP plan that complies with 120.6, 120.7, and 120.8 or otherwise operate in accordance with the requirements of Part 120, renders the juice products 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)). Accordingly, your lemon juice is adulterated, in that it has been prepared, packed or held under insanitary conditions whereby it may have been rendered injurious to health. You may also find the Act, the Current Good Manufacturing Practice (CGMP) regulation for food manufacturers and the juice HACCP regulation through links in FDA's home page at www.fda.gov.

Your significant violations were as follows:

1. You must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 120.8(a). However, your firm does not have a HAACP plan for lemon juice that is manufactured by your firm. Furthermore, your firm does not have a written hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur, and to identify control measures that you can apply to control those hazards.

2. You must adequately monitor conditions and practices during processing with sufficient frequency to ensure conformance with current good manufacturing practice requirements to comply with 21 CFR 120.6(b). However your firm did not monitor prevention of cross contamination from insanitary objects to food and maintenance of hand washing, hand sanitizing and toilet facilities as evidenced by the following observed at your facility:

a. Prevention of Cross Contamination from insanitary objects to food [21 CFR 120.6(a)(3)].

i. On August 11, 2011 an employee on filling line #1 was observed placing fingers inside 8 oz. glass jars to invert the jars immediately prior to filling the jars with food product. The employee was observed inverting jars with their bare hands, folding used boxes, and wiping their hands on soiled clothing.

b. Maintenance of hand washing, hand sanitizing and toilet facilities [21 CFR 120.6(a)(4).

i. The motion activated hand washing sink near the south production area of the green room does not work and there is no way for employees to properly wash their hands during production. Additionally, there wasn't any hot water in the hand washing sink in the employee restrooms located in the north warehouse.

3. You must maintain adequate sanitation standard operating procedure records that at a minimum, document monitoring and corrections, to comply with 21 CFR 120.6(c). However, your firm did not maintain sanitation operating procedure records for the following areas of sanitation:

a. Safety of the water and ice that comes in contact with food or food contact surfaces;

b. Conditions and cleanliness of food contact surfaces, including utensils, gloves and outer garments;

c. Prevention of cross contamination from insanitary objects and raw product to food and food contact surfaces;

d. Maintenance of hand washing, hand sanitizing and toilet facilities;

e. Protection of food and food contact surfaces from adulteration with lubricants, fuel, pesticides, cleaning compounds, sanitizing agents, condensate and other chemical, physical and biological contaminants;

f. Proper labeling, storage, and use of toxic compounds;

g. Control of employee health conditions that could result in the microbiological contamination of food and food contact surfaces; and

h. Exclusion of pests from the food plant.

This letter may not list all the deviations at your facility. You are responsible for ensuring that your firm operates in compliance with the Act, the juice HACCP regulation (21 CFR 120), and the Current Good Manufacturing Practice regulation 110). have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.

Please respond in writing within thirty (30) working days from your receipt of this letter. Your response should outline the specific actions you have taken to correct these deviations. You may wish to include in your response documentation such as your HACCP plan, copies of your Sanitation Standard Operating Procedure, and any other useful information which would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, please include in your response the reason for your delay and state when you will correct any remaining deviations.

Please send your reply to the Food and Drug Administration, Attention: Allison C. Hunter, Compliance Officer, 6751 Steger Drive, Cincinnati, Ohio 45237. If you have questions regarding any issue in this letter, please contact Compliance Officer Hunter at 513-679-2700 extension 2134.

Sincerely,

/s/

Paul J. Teitell
District Director
Cincinnati District