Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New York District
Food & Drug Administration
158-15 Liberty Avenue
Jamaica, NY 11433
December 18, 2014
WARNING LETTER NYK-2015-14
VIA OVERNIGHT MAIL - UNITED PARCEL SERVICE
Mr. Michael Koschitz, President
Wellmill LLC dba Vitamix
69 Mall Drive
Commack, NY 11725
Dear Mr. Koschitz:
The U.S. Food and Drug Administration (FDA) inspected your dietary supplement manufacturing facility, located in 69 Mall Drive, Commack, New York from May 19 through May 30, 2014. During the inspection, our investigator found a number of serious violations of FDA’s 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 the dietary supplement products you contract manufacture, including (b)(4), 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 they have been prepared, packed, or held under conditions that do not meet the CGMP requirements for dietary supplements in 21 CFR Part 111.
We have received your written response, dated June 18, 2014, concerning our investigator’s observations noted on the Form FDA 483, Inspectional Observations, which was issued to you on May 30, 2014. 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.
You may find the Act and FDA’s regulations through links on FDA’s home page at www.fda.gov.
Your dietary supplement products are adulterated based on the following significant violations:
1. Your firm failed to ensure that the tests and examinations that you use to determine whether the specifications are met are appropriate, scientifically valid methods, as required by 21 CFR 111.75(h)(1). Specifically, you conduct organoleptic testing to verify the identity of your powdered dietary ingredients Butcher’s Broom (used in your (b)(4), lot# (b)(4)) and Lactobacillus Acidophilus (used in your (b)(4), lot# (b)(4)). The powdered nature of these ingredients decreases the reliability of organoleptic analysis and may lead to misidentification when organoleptic analysis is the only test used. Therefore, organolepsis is not, by itself, an appropriate, scientifically valid method to verify the identity of your powdered dietary ingredients. We note that you stated that you test approximately (b)(4)% of raw materials for identity by spectroscopy through a contract testing laboratory, and your Raw Material Specification for Butcher’s Broom Powder dated April 11, 2014 indicates that you do such testing for identity on every batch; however, you did not provide any documentation demonstrating that these ingredients were actually tested in this manner. Instead, your Raw Material Release Form for Butcher’s Broom Powder (lot# (b)(4)), dated April 11, 2014, indicates that this ingredient was released for use in production based only on organoleptic, heavy metal, and microbiological testing.
Your June 18, 2014 response indicated that you have installed an FT-NIR Spectrometer that you intend to use to test all incoming raw materials for identity. We intend to verify the adequacy of your corrective action at a future inspection. Furthermore, near-IR spectroscopy is not an adequate and reliable scientific method for confirming the identity of complex proteins or bacteria, such as Lactobacillus acidophilus.
2. Your must make and keep documentation for laboratory tests and examinations that include the results of the testing and examination, as required by 21 CFR 111.325(b)(2)(ii). However, your firm failed to make these records available to FDA during the inspection of your facility (see 21 CFR 111.325(a) and 111.610(a)). Specifically, you stated that you test approximately (b)(4)% of raw materials for identity by spectroscopy through your contract testing laboratory; however, you failed to provide records demonstrating this during the inspection.
Your June 18, 2014 response indicated that you intend to test all incoming raw materials for identity by near-IR spectroscopy in-house. We intend to verify the adequacy of your corrective action at a future inspection.
3. Your firm failed to conduct appropriate tests or examinations to determine compliance with the specifications selected in 21 CFR 111.75(c)(1), as required by 21 CFR 111.75(c)(2). Specifically, you conduct microbial and organoleptic testing on your finished batches of dietary supplements and stated that finished product specifications are met based on production input. However, ensuring that an ingredient is added to the batch of product does not provide adequate assurance that the finished product specifications are met. Moreover, organoleptic testing is not sufficient to verify that your finished batch of dietary supplement meets product specifications for identity because your products contain multiple components that would create a complex organoleptic profile. While microbial testing may be sufficient to verify that your finished batch meets certain product specifications for limits on contamination, microbial testing is not sufficient to verify identity. Furthermore, you did not provide adequate documentation of your basis for determining that compliance with the specifications selected under 21 CFR 111.75(c)(1) through the use of these tests will ensure that your finished batches meet all product specifications for identity, purity, strength, composition, and limits on contamination, as required by 21 CFR 111.75(c)(3).
Your June 18, 2014 response indicated that you are in the process of creating a “Target Finished Product Standard” for all of your finished products. However, your response does not include evidence of the standards and methods that have been completed to date. We intend to verify the adequacy of your corrective action at a future inspection. We also note that you promised a similar corrective action in your April 1, 2013 response to our March 2013 inspection.
4. Your firm failed to include complete information in your batch production record (BPR) relating to the production and control of each batch of dietary supplement, as required by 21 CFR 111.255(b). Specifically, the BPR for your (b)(4) (lot no. (b)(4)) did not include documentation, at the time of performance, of the manufacture of the batch, as required by 21 CFR 111.260(j). The BPR specifies that the final blend of ingredients are mixed “(b)(4)”; however, the BPR was not completed during manufacture of the batch with the date on which this step was performed or the initials of the person performing this step, as required by 21 CFR 111.260(j)(1)-(2).
Your June 18, 2014 response indicated that you have implemented “Good Documentation Practices” and provided a corrected BPR showing the lot number and date of manufacture, and quality control documentation relating to blending time. However, we cannot asses the adequacy of your response because you did not provide documentation that your BPRs now include the blending time recorded at the time of performance. We intend to verify the adequacy of your corrective action at a future inspection. We also note that you provided a similar corrective action in your April 1, 2013 response to our March 2013 inspection.
5. Your firm failed to hold dietary supplements under conditions that do not lead to the mixup of dietary supplements, as required by 21 CFR 111.455(c). Specifically, your firm’s SOP requires that your finished dietary supplement products be held in quarantine status until acceptable results are obtained from laboratory analysis. However, our investigator observed your (b)(4) (lot # (b)(4)), which was supposed to be in quarantine status pending microbiological results, in the “Released Finished Products” area of your facility.
Your June 18, 2014 response indicated that you have increased the spatial separation between the “Quarantined Finished Products” and “Released Finished Products” areas and that you have re-trained your staff. We intend to verify the adequacy of your corrective action at a future inspection.
The violations cited in this letter are not intended to be an all-inclusive statement of violations that 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 ensure that 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 and prevent their further recurrence. Failure to promptly correct these violations may result in enforcement action without further notice, including, without limitation, seizure and/or injunction.
Additionally, we have the following labeling comments:
Your (b)(4) dietary supplement product labeled as (b)(4) declares the ingredients alfalfa powder and non-GMO Soy Lecithin; however, your Batch Production Record indicates that no alfalfa powder and non-GMO Soy Lecithin were added in the manufacture of this product. Your Batch Production Record indicates the ingredient sunflower lecithin was added. You must accurately declare the dietary ingredients contained in the proprietary blend, in accordance with 21 CFR 101.36(c).
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen 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 reinspection-related costs. A reinspection 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. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection 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 reinspection-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 reinspection-related costs.
Please send your reply to the Food and Drug Administration, 158-15 Liberty Avenue, Jamaica, NY 11433, Attention: Kristen C. Jackson. If you have questions regarding any issues in this letter, please contact Kristen Jackson at 718-662-5711.
New York District