Creekside Springs LLC 1/17/12
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Cincinnati District Office |
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-2761
January 17, 2012
Via Overnight Mail
Mr. James J. Sas, President/Treasurer
Creekside Springs, LLC
32 Washington Street
Salineville, Ohio 43945-1078
Dear Mr. Sas:
We inspected your bottled water processing facility located at 32 Washington Street, Salineville, Ohio, on June 30, July 1, 6, and 12, 2011. We found that you are processing bottled water which you label as spring, drinking, and distilled water in violation of the Processing and Bottling of Bottled Drinking Water Regulation (21 CFR Part 129).
By virtue of these violations, the products processed at your facility are 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), because the products have been prepared, packed, or held under unsanitary 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 FDA’s regulations through links on FDA’s Internet home page at www.fda.gov
The following violations were observed during the inspection:
- You failed to provide adequate ventilation in the bottling room to minimize condensation, as required by 21 CFR 129.20(c). Specifically, condensation droplets were observed on a pipe directly above and parallel to the 1 gallon single service container conveyor. Condensation was observed dripping onto the filler head and traveling to the filling nipples where containers are filled prior to sealing.
We have received your response dated October 4, 2011. Although you stated that you modified the protective hoods on conveyor equipment and installed separate air handling equipment to better reduce condensation, your response is inadequate because you failed to submit any documentation or other evidence that would assist us in evaluating your correction.
- You failed to ensure that product water-contact surfaces of all equipment used in the storage of product water are kept clean and adequately sanitized, as required by 21 CFR 129.37(a). Specifically, the FDA investigator observed apparent green algae and black build up on tank surfaces.
We have received your response in which you stated that you modified your procedures to require more frequent inspection of these surfaces and sanitation, However, you did not sufficiently describe the intended procedures. We were therefore unable to evaluate your correction.
- You failed to retain on file at the plant current certificates or notifications of approval issued by the government agency or agencies approving the plant’s source and supply of product water and operations water, as required by 21 CFR 129.80(h). Specifically, your firm was not able to produce documentation from a government agency or agencies approving the source and supply of product water and operations water.
We received your response in which you stated that the relevant certifications are maintained at your administrative offices, located within 1 hour of the operation facility. However, your response is inadequate because all records must be maintained at the plant.
This letter may not list all the violations at your facility. You are responsible for ensuring your firm operates in compliance with the Act and FDA’s implementing regulations, including the bottled water regulations (21 CFR Part 129) and the Current Good Manufacturing Practices regulations (21 CFR Part 110). You should take prompt action to correct these violations. Failure to promptly correct these violations may result in regulatory action, including seizure and/or injunction without further notice.
In addition to the violations discussed above, we have the following comments. In your response dated October 4, 2011, you indicated that you had made a number of corrections. However, you failed to provide documentation of your corrections for the following matters:
- In your response, you indicated that you will utilize a chemical sanitizer with a minimum 100 parts per million of available chlorine at 57ºF or its equivalent. You indicated that you would use this sanitizer in order to address the inspector’s observation that you failed to adequately clean, sanitize, and inspect your multiservice primary containers just prior to the containers being filled, capped, and sealed, as required by 21 CFR 129.80(b)(1). However, you failed to provide documentation of this correction. You should submit documentation on the type of sanitizer used, validation data on effectiveness, and information on any rinsing steps.
- Your response indicated that gallon bottles are shipped in hermetically sealed bags on dedicated bottle delivery trailers. You indicated that the sealed bags would address the inspector’s finding that you failed to handle single service containers in a sanitary manner, as required by 21 CFR 129.37(c). However, you failed to provide documentation of this correction. You should submit additional information on your handling and storage of sealed bags, and cleaning of dust shields.
- In your response, you stated that you modified your firm’s protocols to list both minimum and maximum acceptable ozone levels in finished products. According to your response, the new protocols would address the inspector’s observation that your ozone treatment of the product failed to comply with 21 CFR 129.80(a). However, you failed to provide documentation of this correction. Please submit information on procedures you follow if maximum residual ozone levels are exceeded.
In addition, we note that firms are responsible for sampling and inspecting all containers and closures to ascertain that they are free from contamination. See 21 CFR 129.80(f).
Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you have taken to correct the violations and prevent their recurrence. You should include in your response documentation or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
Please send your reply to the Food and Drug Administration, Attention: Allison C. Hunter, Compliance Officer, and 6751 Steger Drive, Cincinnati, Ohio 45237. If you have questions regarding any issues in this letter, please contact Compliance Officer Hunter at 513-679-2700 extension 2134.
Mr. Paul J. Teitell