Inspections, Compliance, Enforcement, and Criminal Investigations
Halstead Springs, Inc. 29-Jul-05
Department of Health and Human Services
Public Health Service
New Orleans District
July 29, 2005
WARNING LETTER NO. 2005-NOL-30
John E. Beitz, Vice President
Halstead Springs, Inc.
775 Evans Ridge Road
Speedwell, Tennessee 37870
Dear Mr. Beitz:
On May 18, 25-26, 2005, a U. S. Food and Drug Administration (FDA) investigator conducted an inspection of your bottled water manufacturing facility, located at 775 Evans Ridge Road, Speedwell, Tennessee. Our findings revealed deviations from the Current Good Manufacturing Practice (CGMP) regulations, Title 21, Code of Federal Regulations, Part 110 (21 CFR 110) and the Processing and Bottling of Bottled Drinking Water Regulations, Part 129 (21 CFR 129). By virtue of these deviations, the product processed at your facility is adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), [21 United States Code (USC), Section 342(a)(4)], because the product has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. You may find the Act and the CGMP regulations through links in FDA's Internet home page at www.fda.gov.
During our inspection, the investigator provided you with a Form FDA 483, which presents her evaluation of your firm's performance regarding various aspects of the CGMP regulation requirements and the bottled water regulation requirements. The following deviations were listed on the Form FDA 483:
1. Failure to analyze samples of bottled drinking water for chemical testing at least annually, as required by 21 CFR 129.80(g)(2). Specifically, on September 30, 2004, a
sample of your bottled water was submitted to [redacted], for analysis of chemical contaminants. However, the laboratory analysis report dated October 26, 2004, did not include results for chemical, physical, and radiological purposes, as required by 21 CFR 129.80 (g)(2).
2. Failure to analyze samples of product source water for chemical, microbiological, and radiological purposes at defined frequencies, as required by 21 CFR 129.35(a)(3)(i) and consistent with the minimum requirements in 21 CFR 165.100(b). Specifically, on November 19, 2004, a sample of source water was submitted to [redacted], for analysis. However, the laboratory analysis report dated December 20, 2004, did not include all required analyses for chemical, microbiological, and radiological purposes, as required by 21 CFR 129.35(a)(3)(i).
3. Lack of running water of a suitable temperature in hand-washing facilities, as required by 21 CFR 110.37(e). During our inspection on May 18, 2005, the restroom inside your facility did not have running water.
4. Failure to provide sufficient space for placement of equipment and storage of materials as necessary to facilitate maintenance and sanitary operations, and production of safe food, as required by 21 CFR 110.20(b)(1). Specifically, pallets of product, containers, and other items were stored flush against the walls of the warehouse, making inspection and cleaning difficult.
5. Failure to provide adequate screening or other protection against pests, as required by 21 CFR 110.20(b)(7). Specifically, on May 18, 2005, FDA observed numerous dead ladybug type insects in the facility's upstairs and downstairs storage areas and the warehouse area. FDA also observed a substantial gap along the entire bottom length of the roll down door in the warehouse area.
Although not listed on the Form FDA 483, the following deviation was also discussed with you at the conclusion of the inspection:
6. Failure to take a bacteriological swab and/or rinse count at least once every three months from at least four containers and closures selected just prior to filling and sealing, as required by 21 CFR 129.80(f). Specifically, your firm has no verification of the sanitary quality of containers and closures.
This letter may not list all the deviations at your facility. You are responsible for ensuring your firm operates in compliance with the Act, the bottled water regulations (21 CFR 129), and CGMP regulations (21 CFR 110). You should take prompt action to correct these violations. Failure to promptly correct these deviations may result in regulatory action, including seizure and/or injunction without further notice.
Please respond in writing within fifteen (15) working days of your receipt of this letter outlining the specific steps you have taken to bring your firm into compliance with the law. Your response should include each step taken to correct the violations and prevent their recurrence. If you cannot complete all corrections within 15 working days, we expect you to explain the reason for the delay and state when any remaining deviations will be corrected.
Please send your reply to the U.S. Food and Drug Administration, Attention: Kimberly L. McMillan, Compliance Officer, 297 Plus Park Boulevard, Nashville, Tennessee 37217. If you have questions regarding the issues in this letter, please contact Ms . McMillan at (615) 781-5380, extension 138.
H. Tyler Thornburg
Director, New Orleans District