Inspections, Compliance, Enforcement, and Criminal Investigations
El Toro Farm Fresh Cheese Co. 5/2/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Atlanta District Office
60 Eighth Street N.E.
Atlanta, GA 30309
May 2, 2012
Kay C. Elrod, Co-Owner
Elizabeth Elrod, Co-Owner
El Toro Farm Fresh Cheese Co.
Piedmont, SC 29673
Dear Mr. and Mrs. Elrod:
On January 23 – 25, 2012, investigators of the U.S. Food and Drug Administration (FDA) conducted an inspection of your soft cheese processing facility located at C-147-A in Piedmont, South Carolina. During our establishment 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 soft cheese products manufactured in your facility adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic 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.
FDA investigators observed the following serious violations of the CGMP regulation for foods:
- You must ensure that all plant equipment and utensils are so designed and of such material and workmanship as to be adequately cleanable and ensure that all food contact surfaces are corrosion-resistant when in contact with food, to comply with 21 CFR 110.40(a). However, the following objectionable observations regarding your equipment and utensils were made during the inspection:
- The cheese drain trays you use in your cheese processing operations contained pre-drilled, rough-edged holes which cannot be appropriately cleaned.
- The cheese molds you use are constructed of galvanized metal, which has the potential to corrode and contaminate food products. This is a repeat violation.
- The flexible raw product hose was observed to contain an internal ribbed surface that does not enable the hose to be adequately cleaned and sanitized, as evidenced by the accumulation of black grime observed between the ribs.
- You must maintain the instruments used for measuring, recording, and regulating conditions that control or prevent the growth of undesirable microorganisms in food, to comply with 21 CFR 110.40(f). However, you failed to calibrate the indicating, air space, and recording thermometers used in batch pasteurizing of raw milk and the stem and unit thermometers used for the finished product coolers. This is a repeat violation.
- You must maintain the buildings, fixtures, and other physical facilities of the plant in a sanitary condition, to comply with 21 CFR 110.35(a). However, the following objectionable conditions were noted during the inspection:
- The walls, floors, and ceilings throughout the processing room were observed with a build-up of dirt, debris, and cobwebs. This is a repeat violation.
- The wires that connect to the temperature recorder were observed with grime accumulation, while the wires were suspended directly above the batch pasteurizer. This is a repeat violation.
- Grime and milk build-up on the internal surface of the outlet plug valve, indicating thermometer well, recording thermometer well, and the air space thermometer well. This is a repeat violation.
- Build-up was observed on the inside surface of the batch pasteurizer lids and on the centrifugal pump and hose. This is a repeat violation.
- The two hand sinks observed in your production room contain open corrugated seams that allow water or other substances to enter without a means to be efficiently cleaned.
- You must ensure that non-food-contact surfaces of equipment used in the operation of your plant are cleaned as frequently as necessary to protect against contamination of food, to comply with 21 CFR 110.35(d)(3). However, the outside tank used to store raw milk was observed with grime accumulation, particularly around the outlet valve. This is a repeat violation.
- Your plant and facilities must be constructed in such a manner that floors may be adequately cleaned and kept clean and in good repair, to comply with 21 CFR 110.20(b)(4). However, the floors throughout your plant were observed pitted and water eroded. This is a repeat violation. Also, the raised floor platform adjacent to the batch pasteurizer was observed water damaged and with peeling paint.
- You must properly store equipment, remove litter and waste, and cut weeds or grass within the immediate vicinity of the plant buildings or structures that may constitute an attractant, breeding place, or harborage for pests, to comply with 21 CFR 110.20(a)(1). However, our investigators observed the following objectionable conditions:
- A 20’Lx20’Wx4’H pile of melon peels, located approximately 20 yards from the manufacturing facility and serving as an attractant, as evidenced by at least two pigs, five goats, and one peacock on top and around the pile.
- Animal feces on the grounds immediately adjacent to the manufacturing facility, serving as a pest attractant and potential adulterant, as it could have been tracked into the facility.
- A 60’Lx10’Wx6’H pile of woods located approximately 10 yards behind the facility, serving as a potential breeding place or harborage area for pests.
- Unused equipment and miscellaneous items, including barbed wire, 10-gallon drums, and two non-functional food delivery trucks, around the manufacturing facility, serving as a potential breeding place and harborage area for pests.
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.
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 violations and to prevent future violations. You should also describe the procedures you have in place to monitor and control pathogenic microorganisms such as Listeria monocytogenes in your facility to prevent contamination of your ready-to-eat soft cheeses. 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