| Public Health Service Food and Drug Administration |
| New England District One Montvale Avenue Stoneham, Massachusetts 02180 (781) 596-7700 FAX: (781) 596-7896 |
Department of Health and Human Services
WARNING LETTER
NWE-11-10W
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
January 6, 2010
John Bruce Ponton, CEO
Girard Spring Water Co., Inc.
1100 Mineral Spring Avenue
North Providence, Rhode Island 02904
Dear Mr. Ponton:
On August 25, September 3 and 9, 2009, a U.S. Food and Drug Administration (FDA) investigator conducted an inspection of your bottled water manufacturing facility, located at 1100 Mineral Spring Avenue, N. Providence, Rhode Island. Our findings revealed violations of the Processing and Bottling of Bottled Drinking Water regulations (21 CFR 129). By virtue of these violations, 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 (U.S.C), 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 FDA's regulations through links in FDA's Internet home page at www.fda.gov.
The FDA investigator provided you with a form FDA 483, which presents the investigator's observations. The following violations were observed:
1. You have failed to take and analyze samples of source water at a minimum frequency of once each year for chemical contaminants and once every 4 years for radiological contaminants, as required by 21 CFR 129.35(a)(3)(i). Further, you have failed to sample and analyze source water obtained from other than a public water system for microbiological contaminants at least once each week, as required by 21 CFR 129.35(a)(3)(i). The certificates of analysis provided to the FDA investigator do not demonstrate that this requirement has been met.
2. You have failed to take and analyze at least once a week for bacteriological purposes a representative sample from a batch or segment of a continuous production run for each type of bottled drinking water produced during a day's production, as required by 21 CFR 129.80(g)(1). The certificates of analysis provided to the FDA investigator do not demonstrate that this requirement has
been met.
3. You have failed to take and analyze at least annually for chemical, physical, and radiological purposes a representative sample from a batch or segment of a continuous production run for each type of bottled drinking water produced during a day's production, as required by 21 CFR 129.80(g)(2). The certificates of analysis provided to the investigator do not demonstrate that this requirement has been met.
4. You have failed to sample and inspect containers and closures, which includes making a bacteriological swab and/or rinse count at least once each 3 months from at least four containers and closures selected just prior to filling and sealing, to ascertain that they are free from contamination, as required by 21 CFR 129.80(f).
5. You have failed to inspect your mechanical washer as often as is necessary to ensure adequate performance, as required by 21 CFR 129.80(b)(1). Specifically, the monitoring gauges on the mechanical washer were broken and the president of your firm stated that you do not monitor the performance of the machine.
6. You have failed to separate your bottling room from other plant operations or storage areas by tight walls, ceilings, and self-closing doors to protect against contamination, or to ensure that conveyor openings shall not exceed the size required to permit passage of containers, as required by 21 CFR 129.20(a). Specifically, all plant operations are conducted in one large room, including
mechanical bottling, manual bottling, and storage of bottling materials, finished products, shipping cases, chemicals, cleaning agents, and vehicles (a forklift and delivery trucks). The manual filling and capping of (b)(4) containers is done in the open in this room. In addition, the unit in which the mechanical filling of (b)(4) containers takes place has a conveyor opening that exceeds the size required to permit passage of containers.
7. You have also failed to ensure that adequate protection shall be provided to preclude contamination of the water and the system, as required by 21 CFR 129.20(b). Specifically, your bottling room has porous cement walls.
8. You have failed to maintain all records required by 21 CFR 129.1, 129.20, 129.35, 129.37, 129.40 and 129.80 at the plant for not less than 2 years, as required by 21 CFR 129.80(h).
9. You have failed to provide adequate ventilation to minimize condensation in processing rooms, bottling rooms, and in container washing and sanitizing areas, as required by 21 CFR 129.20(c). Specifically, the FDA investigator observed condensate build-up on the overhead pipes and valves in the processing-bottling area.
10. You have failed to ensure that product water-contact surfaces are kept free of scale, evidence of oxidation, and other residue, as required by 21 CFR 129.37(a). Specifically, the FDA investigator observed build up of scale, residue, and rust inside various locations of the mechanical washer/filler chamber where multi-service containers are washed, filled, and capped.
11. You have failed to handle caps or seals in a sanitary manner, as required by 21 CFR 129.37(c). Specifically, the snap-on container caps are stored in a plastic bin that is not adequately cleaned and sanitized; during bottling, some caps are transferred to a smaller plastic container that is not adequately cleaned and sanitized; and there is improper hand washing and sanitizing during the manual capping of product containers.
12. You have failed to fill, cap, close, seal, and package containers in a sanitary manner so as to preclude contamination of the bottled drinking water, as required by 21 CFR 129.37(d). Specifically, the manual filling and capping is not done in a separate, enclosed room; and the exterior of the fill nozzles are not sanitized prior to use.
This letter may not list all the violations at your facility. You are responsible for ensuring your firm operates in compliance with the Act, the bottled water regulations (21 CFR 129), and the Current Good Manufacturing Practice regulations for food (21 CFR 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.
We are in receipt of your fax on September 18, 2009 that responds to the FDA 483 issued to you at the close of the inspection on September 9, 2009. Your response is inadequate because it did not include any documentation or records to show that the violations have been corrected.
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 violations will be corrected.
Please send your reply to the U.S. Food and Drug Administration, Attention: Bruce R. Ota, Compliance Officer, One Montvale Avenue, Stoneham, Massachusetts 02180. If you have any questions regarding this letter please contact Mr. Ota at 781-596-7762.
Sincerely,
/S/
John R. Marzilli
District Director
New England District
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