| Public Health Service Food and Drug Administration |
New Orleans District Telephone: 615-366-7801 |
Department of Health and Human ServicesJune 21, 2010
WARNING LETTER NO. 2010-NOL-15
United Parcel Service
Delivery Signature Requested
Bill Lambert, CEO
David E. Lambert, President
Lambert's Inc.
3588 Old Getwell Road
Memphis, Tennessee 38118
Dear Messrs. Lambert:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your bottled water; coffee roasting; and, flavoring processing facility, located at 3588 Old Getwell Road, Memphis, Tennessee, during March 2-5, 2010. During the inspection, FDA investigators documented serious violations of Title 21, Code of Federal Regulations, Part 110 (21 CFR 110), Current Good Manufacturing Practice regulation for manufacturing foods, 21 CFR 129, Processing and Bottling of Bottled Drinking Water, and subsequently Subpart B, 21 CFR 165, Beverages. The inspection revealed your bottled water and coffee products are adulterated under Section 402(a)(4) [21 United States Code (USC) 342(a)(4)] of the Federal Food, Drug, and Cosmetic Act (the Act) because they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth. You can find the Act and the regulations through links in FDA's Internet home page at www.fda.gov.
The following significant deviations were observed during the inspection:
1. You failed to sample and inspect containers and closures, which includes making a bacteriological swab and/or rinse count at least once each quarter from at least four containers and closures selected just prior to filling and sealing, to ensure they are free from contamination [21 CFR 129.80(f)].
2. You failed to conduct 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 [21 CFR 129.80(g)(1)]. This requirement applies to all finished bottled water products, regardless of source.
3. You failed to conduct 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 [21 CFR 129.80(g)(2)]. This requirement applies to all finished bottled water products, regardless of source.
4. You failed to maintain all records, as required by 21 CFR 129.1, 129.20, 129.35, 129.37, 129.40 and 129.80, at the plant for not less than two years [21 CFR 129.80(h)]. Specifically no records were observed for the following:
• Physical inspections of equipment used for treating product water, conditions found, and the performance and effectiveness of such equipment [21 CFR 129.80(a)];
• Physical maintenance, inspections and conditions found, and performance of the mechanical washer [21 CFR 129.80(b)(1)];
• Sampling and testing of cleaning and sanitizing solutions utilized by the plant [21 CFR 129.80(c)];
• The intensity of the sanitizing agent and the time duration the agent was in contact with the surface being sanitized [21 CFR 129.80(d)]; and,
• Records of testing for finished products for chemical, physical, and radiological purposes [21 CFR 129.80(g)(3)].
5. You failed to ensure sanitizing operations are adequate to effect sanitation of the intended product water-contact surface [21 CFR 129.80(d)]. Specifically, you are relying on (b)(4) to "sanitize" your water holding tank (b)(4) every (b)(4) through the process of (b)(4) through the tank for a period of (b)(4) without determining if the level of (b)(4) meets the minimum standard specified in 21 CFR 129.80(d)(4) of 0.1 ppm (b)(4) in an enclosed system for at least (b)(4).
6. You failed to ensure the treatment of product water by (b)(4) is done in a manner effective in accomplishing its intended purpose and in accordance with Section 409 of the Act [21 CFR 129.80(a)]. Specifically, you failed to demonstrate your (b)(4) process results in a maximum residual level at the time of bottling which does not exceed 0.4 mg/1 [21 CFR 184.1563].
7. You failed to adequately clean, sanitize and inspect your multisevice primary containers just prior to the containers being filled, capped, and sealed [21 CFR 129.80(b)(1)].Specifically, returned containers are inspected by smell; and, sight only; you do not have records demonstrating the returned containers are screened, and you do not have a clear policy for handling dirty bottles, despite bottles being returned previously with a "diesel fuel smell". There is no evidence you have validated the temperature gauge on the bottle cleaning apparatus.
8. You failed to confirm your cleaning solution is an approved sanitizer, as listed in 21 CFR 178.1010, and if it is not an approved sanitizer, you are following the alternate criteria listed in 21 CFR 129.80(d)(5). Specifically, you are unfamiliar with the contents of your bottle wash solution and could not provide any information confirming it is an approved sanitizer. You reportedly test containers for residual soap, but have not offered information on this process.
9. You failed to ensure the mechanical bottle washers are inspected as often as is necessary to assure adequate performance [21 CFR 129.80(b)(1)]. Specifically, the FDA investigator observed rusting fill heads on the bottle neck inversion part of the mechanical washer.
10. You failed to fill, cap, close, seal, and package containers in a sanitary manner so as to preclude contamination of the bottled drinking water [21 CFR 129.37(d)]. Specifically, the manual filling and capping is not done in a separate, enclosed room; and, filled bottles are left open on a conveyor until an employee caps them by hand [21 CFR 129.20(a)].
11. Failure of employees to avoid a source of contamination of the multi-service containers [21 CFR 110.10(b)(3) and (5)]. A gloved employee was observed to handle dirty, returned multi-service water containers and "clean" newly filled multi-service containers without cleaning or sanitizing his gloves in between the two processing steps.
12. Failure to maintain the food manufacturing facility to reduce the potential for contamination with filth while producing bottled water, coffee roasting and flavoring, and coffee grinding and packaging operations [21 CFR 110.20(b)(2)]. The coffee and the bottled water manufacturing operations are conducted in the open warehouse facility, which has abundant cobwebs, dust and dirt observed on the ceilings, walls and fixtures.
Your Glacier Mountain bottled water and Ugly Mug Coffee products are misbranded within the meaning of Section 403(a)(1) of the Act [21 USC 343(a)(1)] because the labeling is false and misleading. For example:
• The statements "Pure Artesian Well Water", "From the Memphis, TN Artesian Wells", and "DEIONIZATION" on the labels of your Glacier Mountain product are false and misleading. Artesian well water is defined as water from a well tapping a confined aquifer in which the water level stands at some height above the top of the aquifer [21 CFR 165.110(a)(2)(i)]; however, you informed our investigators your water is obtained from a municipal water source. Our investigators observed your product is not deionized, as defined by 21 CFR 165.110(a)(2)(iv), but rather is treated by (b)(4).
• The statement "PERU/COSTA RICA" on the labeling of your Ugly Mug Coffee product expresses a geographical origin of the food which is not truthful [21 CFR 101.18(c)]. On March 2, 2010, our investigators observed your employees package coffee beans of
• (b)(4) origin into Ugly Mug coffee packages which were labeled "PERU/COSTA RICA."
Your Glacier Mountain bottled water product is misbranded within the meaning of Section 403(g)(1) of the Act [21 USC 343(g)(1)] because it purports to be a food for which a definition and standard of identity has been prescribed by regulation but it fails to conform to such definition and standard. For example:
• Your product labels do not state "from a community water system" or "from a municipal source" as appropriate on the principal display panel. This statement shall immediately and conspicuously precede or follow the name of the food without intervening material [21 CFR 165.110(a)(3)(ii)].
Your Glacier Mountain bottled water product is misbranded under Section 403(i)(1) of the Act [21 USC 343(i)(1)] because the products fail to bear the common or usual name of the food. For example:
• The principal display panels of your Glacier Mountain bottled water labels do not bear a statement of the identity of the commodity [21 CFR 101.3(a) and 165.110].
Your Ugly Mug Coffee, Lambert's Coffee® Roasters [Cafe Colombia, Special Reserve (blue label), Special Reserve (gold label)], and Glacier Mountain products are misbranded within the meaning of Section 403(e)(1) and/or (2) [21 USC 343(e)(1) and/or (2)] because the packages do not contain the place of business of the manufacturer, packer, or distributor and do not contain a statement of the quantity of the contents. For example:
• Your Ugly Mug Coffee product label inaccurately lists the name of the manufacturer, packer, or distributor as "Ugly Mug Coffee Co." You informed our investigators (b)(4) was no longer in business. The requirement for declaration of the name of the manufacturer, packer, or distributor shall be deemed to be satisfied, in the case of a corporation, only by the actual corporate name, which may be preceded or followed by the name of the particular division of the corporation [21 CFR 101.5(b)].
• Your Glacier Mountain product labels do not include the name and place of business of the manufacturer, packer, or distributor [21 CFR 101.5(a)].
• Your Glacier Mountain bottled water labels and your Lambert's Coffee® Roasters product labels do not bear a declaration of the net quantity of contents [21 CFR 101.1 05(a)].
This letter is not intended to be an all inclusive review of your manufacturing practices. It is your responsibility to ensure all products marketed by your firm comply with the Act and the applicable regulations. You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure and/or injunction.
We offer the following comments regarding the labeling of your Lambert's Coffee® Roasters products:
• Regarding the product labeled "Cafe Colombia", unless this is a truthful representation of geographical origin of the food, this statement would render the food misbranded [21 CFR 101.18(c)(1)].
• The principal display panels of your Lambert's Coffee® Roasters products do not state the particular form of the food (e.g. ground or whole bean) [21 CFR 101.3(a) and (c)].
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Your response should be sent to U.S. Food and Drug Administration, Attention: Kari L. Batey at the above address. If you have any questions about the content of this letter, please contact Ms. Batey at (615) 366-7808.
Sincerely,
/S/
Patricia K. Schafer
Acting District Director
New Orleans District
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