Urban Moonshine, Inc. 11/20/14
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||New England District Office|
One Montvale Avenue, 4th floor
Stoneham, MA 02180
CMS # 418270
VIA United Parcel Service
November 20, 2014
Ms. Jovial King
Owner and CEO
Urban Moonshine, Inc.
255 S. Champlain St., Suite 3
Burlington, VT 05401
Dear Ms. King:
On December 4, 2013 through December 16, 2013, the U.S. Food and Drug Administration (FDA) inspected your firm located at 255 S. Champlain St., Suite 3, Burlington, Vermont. During the inspection, our investigator found a number of violations of the Current Good Manufacturing Practice (CGMP) regulations for Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). These violations cause dietary supplement products manufactured by your firm, including Nettles, Milky Oats, and Immune Zoom, 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)] in that the products have been prepared, packed, or held under conditions that do not meet the CGMP requirements for dietary supplements in 21 CFR Part 111. You may find the Act and FDA’s implementing regulations through links on FDA’s home page at http://www.fda.gov
We have received your written response on January 8, 2014, concerning our investigator’s observations noted on the Form FDA 483, Inspectional Observations, which was issued to you on December 16, 2013. Our comments regarding the adequacy of the actions you took to correct the objectionable conditions and practices observed during the inspection are detailed after the applicable violations, noted below.
Your significant violations are as follows:
Dietary Supplement CGMP Violations
1. You failed to establish product specifications for the identity, purity, strength, and composition of the finished batch of a dietary supplement, and for limits on those types of contamination that may adulterate, or that may lead to adulteration of, the finished batch of the dietary supplement to ensure the quality of a dietary supplement, as required by 21 CFR 111.70(e). For example, the documents you provided for Immune Zoom do not demonstrate that you have product specifications for the identity, purity, strength, and composition of the finished batch of the dietary supplement, and for limits on those types of contamination that may adulterate, or that may lead to adulteration of, the finished batch of the dietary supplement. You provided a document entitled “(b)(4)” dated (b)(4) that contained “(b)(4)” of your finished product, including only requirements for the finished product’s relative density, opacity, and organoleptic description. These specifications are inadequate to establish identity because these physical tests are not capable of identifying individual ingredients within a multi-ingredient product. Moreover, these specifications do not relate to the purity, strength, or composition of the finished product, nor do they establish limits on those types of contamination that may adulterate, or that may lead to the adulteration of, the finished batch of the dietary supplement.
Your response is inadequate as it did not address whether you have established additional specifications for your finished dietary supplements.
2. You failed to establish component specifications for identity that are necessary to ensure that the specifications for the purity, strength, and composition of the dietary supplements manufactured using the components are met, and limits on those types of contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(b). Specifically, we reviewed your batch records for your dietary supplement Nettles (b)(4), Milky Oats (b)(4), and Immune Zoom (b)(4), including records titled “(b)(4)” and “(b)(4)” for various components used in those products. We identified no evidence that your firm has established identity specifications for components ((b)(4)) used in Immune Zoom. Additionally, we identified no evidence that your firm has established component specifications relating to purity, strength, composition, or limits on contamination for the components used in Nettles, Milky Oats and Immune Zoom.
Your response included new monographs for certain components. We find your response to be inadequate. You did not address the lack of identity specifications for components of Immune Zoom; or the lack of purity, strength, and composition specifications, and limits on contamination, for components used in Nettles, Milky Oats, or Immune Zoom. We acknowledge that your response included a “(b)(4),” however, this procedure does not include limits on contamination for specific components used in your dietary supplements.
3. You failed to prepare and follow a written master manufacturing record (MMR) for each unique formulation of dietary supplement that you manufacture, and for each batch size, in accordance with 21 CFR 111.205(a). For example, the MMR you provided during the inspection for the dietary supplement Immune Zoom was not specific to this product and batch size, and is the same MMR utilized to manufacture products other than Immune Zoom, such as Nettles and Milky Oats.
In addition, the MMR for each unique formulation of dietary supplements that you manufacture, and for each batch size, must include all information required under 21 CFR 111.210.
Your firm’s response is inadequate as it only contains corrective actions for verifying weighing and blending operations. It did not contain any information regarding maintaining specific MMRs for each unique formulation of dietary supplement that you manufacture.
4. Your firm failed to include complete information relating to the production and control of each batch on your batch production records, as required by 21 CFR 111.255(b) and set forth under 111.260. For example, your firm’s batch production record for Immune Zoom, batch number 30, did not include all required information, including, but not limited to:
a) The identity of equipment and processing lines used in producing the batch, 21 CFR 111.260(b);
b) The date and time of the maintenance, cleaning and sanitizing of the equipment and processing lines used to manufacture the batch, or cross references to such records, 21 CFR 111.260(c);
c) The unique identifier that your firm assigned to the packaging and labels used, 21 CFR 111.260(d).
d) Documentation that the finished dietary supplement meets its specifications in accordance with 21 CFR 111.70(e) and 21 CFR 111.70(g), 21 CFR 111.260(i);
e) Documentation, at the time of performance, of the manufacture of the batch, 21 CFR 111.260(j), of the following:
1. The date on which each step of the master manufacturing record was performed;
2. The initials of the persons performing each step, including:
i. The initials of the person responsible for adding the component to the batch;
ii. The initials of the person responsible for verifying the addition of components to the batch.
f) Documentation, at the time of performance, of packaging and labeling operations, 21 CFR 111.260(k);
g) Documentation, at the time of performance, that quality personnel (21 CFR 111.260(l)):
1. Reviewed the batch production record;
2. Approved or rejected any reprocessing or repackaging;
3. Approved and released, or rejected, the batch for distribution, including any reprocessed batch;
4. Approved and released, or rejected, the packaged and labeled dietary supplement, including any repackaged or relabeled dietary supplement.
h) Documentation, at the time of performance, of any required material review and disposition decision, 21 CFR 111.260(m);
i) Documentation, at the time of performance, of any reprocessing, 21 CFR 111.260(n).
Your firm’s response is inadequate as the batch records you provided as examples did not contain all of the requirements stated above.
Misbranded Dietary Supplements
Your Immune Zoom (2 fl oz)(59.1 ml), Nettle (2 fl oz)(59 ml), and Milky Oats (2 fl oz)(59 ml), products are misbranded within the meaning of Sections 403(q)(5)(F) and 403(s)(2)(A) of the Act [21 U.S.C. 343(q)(5)(F) and 343(s)(2)(A)] in that these labels fail to present nutrition information, including the quantitative amount by weight per serving for each dietary ingredient in an enclosed box using the title “Supplements Facts” as defined in 21 CFR 101.36.
This letter is not intended to be an all-inclusive list of violations at your facility or that exist in connection with your products or their labeling. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations.
You should take prompt action to correct the violations described above and prevent their further recurrence. Failure to do so may result in enforcement action, without further notice, including, but not limited to, seizure and/or injunction of violative products.
In addition to the violations cited above, we have the following comment:
- A dietary supplement manufacturer is required to have quality control personnel approve or reject all processes, specifications, written procedures, controls, tests, and examinations, and deviations from or modifications to them, that may affect the identity, purity, strength, or composition of a dietary supplement, as required by 21 CFR 111.105(a). We note that the monograph for fresh Nettles, which you provided to our investigator during the inspection, does not include any indication that it was reviewed and approved by quality control. Moreover, your response does not indicate whether quality control reviewed and approved the monograph.
Please notify this office in writing within fifteen (15) working days of receipt of this letter as to the specific steps that you have taken to correct the above-listed violations and to ensure that similar violations will not recur. Your response should include any documentation necessary to show that the correction has been achieved. If corrective action cannot be completed within fifteen working days, state the reason for the delay and the time frame within which the corrections will be made.
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 re-inspection-related costs. 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, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees (21 U.S.C. 379j-31(a)(2)(B)). For a 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 noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
Please direct your written reply to the U.S. Food and Drug Administration, One Montvale Avenue, Stoneham, MA 02180, Attention: Todd Maushart, Compliance Officer. If you have any questions about the content of this letter please contact: Todd Maushart at (781) 587-7578.
Mutahar S. Shamsi
New England District