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  5. Perfect Water and Essentials LLC, dba Aquagen International - 12/10/2015
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WARNING LETTER

Perfect Water and Essentials LLC, dba Aquagen International 10/12/2015

Perfect Water and Essentials LLC, dba Aquagen International - 12/10/2015


Recipient:
Perfect Water and Essentials LLC, dba Aquagen International


United States

Issuing Office:
Denver District Office

United States


  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
Denver District Office
Bldg. 20-Denver Federal Center
 P.O. Box 25087
6th Avenue & Kipling Street
Denver, Colorado 80225-0087
Telephone: 303-236-3000              
FAX:        303-236-3100

 

December 10, 2015
 
 
WARNING LETTER
 
 
VIA UPS Overnight Delivery
 
Ref: DEN-16-03-WL
 
 
Mr. Greg Mortensen, CEO, Co-Owner
Perfect Water and Essentials, LLC,
dba Aquagen International
2484 Custer Rd,
Salt Lake City, UT 84104-4265
 
 
Dear Mr. Mortensen,
 
The U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 2484 W. Custer Rd, Salt Lake City, Utah, from August 3-6, 2015. The inspection revealed serious violations of FDA’s regulations for Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111). These violations cause the 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 U.S.C. § 342(g)(1)] because they have been prepared, packed, or held under conditions that do not meet CGMP regulations. We have also reviewed product labels collected during the inspection and have determined that your labels cause certain products to be misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343] and the implementing regulations under 21 CFR Part 101. You may find the FDA regulations and the Act through links on FDA’s home page at http://www.fda.gov.
 
We have reviewed your written response dated September 16, 2015, submitted in response to the FDA-483 issued to you at the close of the inspection. We have included some detailed comments regarding your response below.
 
Adulterated Dietary Supplements
 
The following conditions were observed during the inspection of your facility and demonstrate your firm’s failure to comply with the CGMP regulations in 21 CFR Part 111:
 
1.    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, as required by 21 CFR 111.75(a)(1)(i), unless FDA grants an exemption under 21 CFR 111.75(a)(1)(ii). Specifically, you do not perform laboratory testing on any component that is a dietary ingredient, including sodium chloride and potassium hydroxide, and FDA has not granted an exemption under 21 CFR 111.75(a)(1)(ii).
 
We have reviewed your written response dated September 16, 2015. We are unable to determine the sufficiency of your response. While your response stated that “testing will now be completed before raw goods can be released for use,” you did not specifyied what kind of testing you plan to perform.
 
2.    You failed to preparea written master manufacturing record (MMR) for each unique formulation of dietary supplement that you manufacture, and for each batch size, to ensure uniformity in the finished batch from batch to batch, as required by 21 CFR 111.205(a). Specifically, you failed to prepare a master manufacturing record for each batch size of the formulation you manufactured for bulk fluids that are used in some of your dietary supplement products.
 
We have reviewed your written response dated September 16, 2015. We are unable to determine the sufficiency of your response because you only provided a blank Master Copy for the Essential Bulk Fluid, but did not include a separate MMR for the Essential Oxygen product that you package and label in retail size.
 
3.    Your batch production records (BPRs) failed to include complete information relating to the production and control of each batch, as required by 111.255(b). Specifically, your BPRs failed to include the following, as required by 111.260:
 
a)    The date and time of the maintenance, cleaning, and sanitizing of the equipment and processing lines used in producing the batch, or a cross-reference to records, such as individual equipment logs, where this information is retained, as required by 21 CFR 111.260(c);
b)    Documentation, at the time of performance, of the manufacture of each batch, including the initials of the persons performing each step, as required by 21 CFR 111.260(j)(2);
c)    Documentation, at the time of performance, of packaging and labeling operations, including the unique identifier that you assigned to bulk packaging used and the quantity of the bulk packaging used, as required by 21 CFR 111.260(k)(1).
 
We have reviewed your written response dated September 16, 2015. We are unable to determine the sufficiency of your response because you only provided a blank MMR, which you also used as a BPR, which does not support that you have implemented your corrective action. Additionally, while you have provided completed cleaning logs, the logs do not include the time of performance or the maintenance of equipment.
 
4.   You failed to establish and follow written procedures to meet the requirements for the components, packaging, and labeling, as required by 21 CFR 111.153. Specifically, you did not make and keep records of inspections performed for incoming materials and components to demonstrate the materials and components have been verified against their purchase order, certificate of analysis, and established specifications. Under 21 CFR 111.180(b)(2), the written procedures you must establish and follow include making and keeping receiving records for components, packaging, and labels.
 
We have reviewed your written response dated September 16, 2015. Your response is inadequate because you only provided a blank receiving form which does not support that you have implemented your corrective action.
 
Misbranded Dietary Supplements
 
1.    Your Alkaline Drops product is misbranded within the meaning of section 403(s)(2)(B) of the Act [21 U.S.C. § 343(s)(2)(B)] because the label fails to include a statement of identity as a “dietary supplement” as required by 21 CFR 101.3(g).
 
2.    Your Alkaline Drops product is misbranded within the meaning of section 403(y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement.
 
3.    Your Alkaline Drops product is misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] in that it fails to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5. Specifically, yourproduct label fails to list the city, state, and zip code of the place of business, as required by 21 CFR 101.5(d).
 
4.    Your Alkaline Drops product is misbranded within the meaning of section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the serving size declared on the label is not expressed in a common household measure that expresses the serving size of the food. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. The directions of use on the product label suggests the consumer take “5 mL (1/2 dropper full) with water” or “approximately 10-12 drops,” but the serving size lists “.5 mL.” 
 
5.    Your Essential Oxygen and Maximum Performance Oxygen  products are misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] in that the presentation of the nutrition information on the labeling of your product does not comply with 21 CFR 101.36. Specifically, any dietary ingredients that have a Reference Daily Intake (RDI) or a Daily Reference Value (DRV) as established in 21 CFR 101.9(c) (referred to as “(b)(2)-dietary ingredients”), such as Calories, Total Fat, Total Carbohydrates, Sugars, and Protein, that are not present, or that are present in amounts that can be declared as zero in 21 CFR 101.9(c), shall not be declared, in accordance with 21 CFR 101.36(b)(2)(i).
 
The violations described above are not meant to be an all-inclusive list of violations at your facility or that exist in connection with your products or their labeling. 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 ensure that your firm complies with the Act and applicable FDA regulations. 
 
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in enforcement action without further notice, including, without limitation, injunction and seizure under section 302 and 304 of the Act [21 U.S.C. §§ 332 and 334].
 
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct the violations cited in this letter. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of the related documentation. If you cannot complete corrective actions within fifteen (15) working days, state the reason for the delay and the time within which you will complete the correction.
 
Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including costs associated with re-inspection. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act; “costs” means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and domestic facility. FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any costs related to re-inspection.
 
Your written response should be directed to the U.S. Food and Drug Administration, Attention: Hanna L. Potter, Compliance Officer, at the above address. If you have questions about this letter, please contact Ms. Potter at (303) 236-3094.
 
 
Sincerely,
/S/ 
LaTonya M. Mitchell
Denver District Director

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