Inspections, Compliance, Enforcement, and Criminal Investigations
Prismic Light International 6/28/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|New Orleans District |
404 BNA Drive
Building 200-Suite 500
Nashville, TN 37217
Telephone: (615) 366-7801
FAX: (615) 366-7802
June 28, 2012
WARNING LETTER NO. 2012-NOL-25
UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
Timothy M. Sanders, DDS, Owner
Prismic Light International
4711 Sulphur Springs Road
Murfreesboro, Tennessee 37129-7201
Dear Dr. Sanders:
On January 18-19, and 23, 2012, investigators with the U.S. Food and Drug Administration (FDA) conducted an inspection of your facility, located at 4711 Sulphur Springs Road, Murfreesboro, Tennessee. The inspection revealed you have failed to comply with the Current Good Manufacturing Practice (CGMP) regulations for dietary supplements, Title 21, Code of Federal Regulations (CFR), Part 111. These violations cause the dietary supplement products manufactured at your facility to be adulterated within the meaning of Section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 United States Code (USC) 342(g)(1)] because they have been prepared, packed, or held under conditions which do not meet the CGMP regulations for dietary supplements. Our investigators' observations were noted on the FORM FDA 483, Inspectional Observations, issued to you on January 23,2012.
In addition, FDA reviewed the labeling of your products, including your Internet websites at http://www.sandentco.com and http://www.prismiclight.com in June 2012. Based on our review of the labeling for your Cell Renew and Cell Silver products, we have determined these products are promoted for conditions which cause the products to be drugs under Section 201(g)(1)(B) of the Act [21 USC 321(g)(1)(B)]. The claims made in the labeling for these products establish that your products are drugs because they are intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease of the human body. The marketing of your products with these claims violates the Act.
Furthermore, our review of your labels and other evidence collected during the inspection indicate your firm's Cell Renew, Cell Renew Essential Silica, and Cell Silver products are misbranded within the meaning of Section 403 of the Act [21 USC 343] and its implementing regulations in 21 CFR 101. You may find the Act and FDA regulations through links on FDA's Internet home page at http://www.fda.gov.
Dietary Supplement CGMP Violations:
1. You failed to implement a system of production and process controls which covers all stages of manufacturing, packaging, labeling, and holding of dietary supplements to ensure the quality of the dietary supplement and the dietary supplement is packaged and labeled, as specified in the master manufacturing record [21 CFR 111.55]. You do not have any written procedures or other documentation to show that a system of production and process controls has been implemented.
2. You failed to identify and hold in-process material under conditions which protect against mix-up, contamination, and deterioration [21 CFR 111.460(a)]. Investigators found in process materials for different product formulations stored in unlabeled plastic containers along with unlabeled finished products your facility.
3. You failed to establish a specification for any point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and the dietary supplement is packaged and labeled, as specified in the master manufacturing record [21 CFR 111.70]. You have not established product specifications [21 CFR 111.70(e)] or in-process specifications [21 CFR 111.70(c)]. For example, your firm's Cell Renew product is comprised of (b)(4). For the initial (b)(4), the amount of (b)(4) is estimated, and the amount of (b)(4) added is measured using a (b)(4). In addition, your Cell Silver product is comprised of (b)(4). The volume of (b)(4) in the formulation are estimated. Since component ingredients are estimated and not accurately measured, finished products may vary in strength and composition.
4. You failed to conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient, prior to its use [21 CFR 111.75(a)(1)(i)]. You do not conduct tests or examinations to verify the identity of the dietary ingredients used in the manufacture of the three dietary supplement formulations you manufacture. You stated to our investigators you do not know the contents of the (b)(4), other than it is a combination of (b)(4) put together in a proprietary way.
5. You failed to establish and follow written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review; making a disposition decision; and, for approving or rejecting any reprocessing [21 CFR 111.103]. We note, "In general, CGMP suggests the need for a minimum of two persons: One to perform the work, and a second to check the work performed to ensure that a manufacturing deviation or an unanticipated occurrence is not overlooked" [72 Federal Register 34752 at 34810 (June 25, 2007)].
6. You failed to prepare and follow a written master manufacturing record for each unique formulation of dietary supplement you manufacture, and for each batch size, to ensure uniformity in the finished batch [21 CFR 111.205(a)]. Specifically, written master manufacturing records for the different dietary supplement products manufactured by your firm. to include Cell Renew and Cell Silver, have not been established.
7. You failed to prepare a batch production record [21 CFR 111.555 and 111.260]. You must prepare a batch product record every time you manufacture a batch of a dietary supplement [21 CFR 111.255(a)]. However, you do not maintain production records and you were uncertain of the date(s) on which the last batch of dietary supplements was manufactured at your firm.
8. You failed to collect and hold reserve samples of each lot of packaged and labeled dietary supplements you distribute [21 CFR 111.83(a)]. For example, you do not maintain reserve samples for Cell Renew or Cell Silver (which are manufactured on-site); Cell Renew HGH (which is manufactured and labeled for Prismic Light International by another manufacturer); or Cell Renew Essential Silica (which is manufactured for Prismic Light International by another firm, but labeled on-site).
9. You failed to establish and maintain written procedures for fulfilling the requirements related to equipment and utensils [21 CFR 111.35(b)(1)]. Specifically, there are no . written procedures for calibrating, inspecting, and checking automated, mechanical, and electrical equipment; for maintaining, cleaning, and sanitizing equipment; and, any other contact surfaces which are used to manufacture, package, label, or hold components or dietary supplements.
10. You failed to calibrate instruments and controls you use in manufacturing a dietary supplement [21 CFR 111.27 (b)] and to ensure the equipment functions in accordance with its intended use [21 CFR 111.30]. Specifically, when asked if the filling machine was calibrated to dispense the correct volume of product into bottles, you told our investigator it was not. You told our investigators you use a clear bottle to visually determine if the volume dispensed is acceptable. You also stated to our investigators the filler was inaccurate and sometimes dispensed too much or not enough.
11. You failed to make and keep records of the written procedures for cleaning the physical plant and for pest control [21 CFR 111.23(b)]. Specifically, you do not have any written procedures.
12. You failed to establish written procedures to fulfill the requirements related to product complaints [21 CFR 111.553]. Specifically, you have not established written procedures for the review and investigation of product complaints.
13. You failed to establish written procedures to fulfill requirements related to returned dietary supplements [21 CFR 111.503]. Specifically, you have not established written procedures that identify the procedures to be followed when a dietary supplement is returned by a customer.
Unapproved New Drugs
Based on our review of the labeling for your products, we have determined your Cell Renew and Cell Silver products are promoted for conditions which cause the products to be drugs under Section 201(g)(1)(B) of the Act. The therapeutic claims on your websites and on the product labels for the aforementioned products establish these products are intended for use in the cure, mitigation, treatment, or prevention of disease in humans. The marketing of your products with these claims violates the Act.
Examples of some of the claims observed in labeling for your products include:
• "CELL RENEW® releases oxygen from water. Oxygen is known to inhibit infectious bacteria, viruses, fungi, and parasites!"
• "The powerful bacteriostatic ... effects of CELL RENEW®"
• "When we became aware of a very special Angstrom sized Silver, Copper and Zinc mixture that the Chinese government used to end the SARS epidemic and stopped West Nile and parvo, we knew that we had the answer. The answer is CELL SILVER .... "
• "These minerals help fight off and kill viruses, bacteria, fungi and parasites ... "
• "Angstrom Silver will kill only the harmful or nitrogen breathing, anaerobic bacteria. .. Silver, Copper & Zinc work together to kill viruses by breaking down the protein shield surrounding them."
• Ingredient of Cell Silver - Copper
o "Copper ... may be useful in helping with the lung damage of emphysema"
o "Copper will cause Parasites to leave the system"
• Ingredient of Cell Silver Zinc
o "Zinc ... stops viral and bacterial replication"
Your products are not generally recognized as safe and effective for the above referenced uses, and therefore, the products are "new drugs" under Section 201(p) of the Act [21 USC 321(p)]. A new drug may not be legally marketed in the United States without prior approval from FDA, as described in Section 505(a) of the Act [21 USC 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate the drug is safe and effective.
1. Your Cell Renew, Cell Renew Essential Silica, and Cell Silver products are misbranded within the meaning of Section 403(q)(S)(F) of the Act, because the presentation of nutrition information on the labeling for your product does not comply with 21 CFR 101.36. For example:
• The individual trace minerals, amino acids, enzymes, and dietary ingredients contained in the proprietary blend of these products are not declared within the "Supplement Facts" panel, as required under 21 CFR 101.36(b)(2) and 101.36(b)(3).
• The Cell Silver product label does not segregate the 21 CFR 101.36(b)(2) and (b)(3) dietary ingredients into separate sections of the Supplement Facts panel, as required by 21 CFR 101.36(b)(3)(i).
• The Cell Silver product label does not declare the quantitative amount by weight in each serving using the units of measurement given in 21 CFR 101.9(c)(8)(iv) and the percent of the Daily Value(% DV).for each 21 CFR 101.36(b)(2) dietary ingredient (copper and zinc), as required by 21 CFR 101.36(b)(2) and 101.36(b)(3).
• The products labels for Cell Renew and Cell Silver list ingredients such as "Purified water" and "dissolved oxygen" inside the Supplement Facts panel. Under 21 CFR 101.4(g), these ingredients must be listed immediately below the nutrition label, or, if there is insufficient space below the nutrition label, immediately contiguous and to the right of the nutrition label. These ingredients must be preceded by the word "Ingredients," unless some ingredients (i.e., sources) are identified within the nutrition label in accordance with 21 CFR 101.36(d).
2. Your Cell Renew Essential Silica, Cell Renew, and Cell Silver products are misbranded within the meaning of Section 403(s)(2)(B) of the Act, because the labels fail to identify the products using the term dietary supplement [21 CFR 101.3 (g)].
3. Your Cell Renew Essential Silica and Cell Silver products are misbranded within the meaning of Section 403(y) of the Act, because the label fails to include a complete domestic address or domestic phone number through which the responsible person [as described in Section 76l(b)] may receive a report of a serious adverse event with such dietary supplement.
The violations cited in this letter are not intended to be an all inclusive statement of violations which exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to assure your firm complies with all requirements of federal law and FDA regulations. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and/or injunction.
In addition to the above violations, we have the following comments:
• You failed to provide hand washing facilities which are designed to ensure an employee's hands are not a source of contamination of components, dietary supplements, or any contact surface, by providing facilities which are adequate, convenient, and furnish running water at a suitable temperature [21 CFR 111.15(i)]. Specifically, you installed a hand wash sink in the filling room based upon your prior inspection of 2008 which is not conventionally plumbed. As observed, an electric pump is used to pump water held in a plastic jug through the faucet, and in order to operate, the pump must be plugged into an electrical outlet. Furthermore, the sink has no hot water.
• During the inspection, our investigators observed unlabeled cardboard shipping cartons you identified as containing Cell Rescue for export to (b)(4). It is your responsibility under Section 801(e) of the Act [21 USC 381(e)] to ensure your product for export (1) accords to the specifications of the foreign purchaser; (2) is not in conflict with the laws of the country to which it is intended for export; (3) is labeled on the outside of the shipping package it is intended for export; and, (4) is not sold or offered for sale in domestic commerce.
• During the inspection, our investigators observed equipment, including the filler heads and labeling line, with caked-on residue. You were not able to verify when the specific pieces of equipment were last used. Please note, under 21 CFR 111.27(d), you are required to maintain, clean, and sanitize, as necessary, all equipment, utensils, and any other contact surfaces used to manufacture, package, label, or hold components or dietary supplements. We recommend you take your equipment and utensils apart as necessary for thorough cleaning and sanitizing before using them in the manufacture of dietary supplement products.
You are requested to notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific 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 actions you have taken. If your planned corrections will occur over time, please include a timeframe for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time in which the corrections will be completed.
Please send your reply to Karl L. Batey, Compliance Officer, Food and Drug Administration, at the above address. Any questions you may have regarding this process should be directed to Ms. Batey at (615) 366-7808.
Patricia K. Schafer
New Orleans District
Enclosure: FDA 483 dated January 23, 2012