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  5. Windmill Health Products, LLC - 10/07/2014
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WARNING LETTER

Windmill Health Products, LLC


Recipient:
Windmill Health Products, LLC


United States

Issuing Office:
New Jersey District Office

United States


  

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

Public Health Service
Food and Drug Administration
 New Jersey District Office
Central Region
Waterview Corporate Center
10 Waterview Blvd. 3rd Floor
Parsippany, New Jersey 07054
Telephone: (973) 331-4900
FAX: (973) 331- 4969
 

October 7, 2014
 

Via United Parcel Service
Overnight Delivery

Mr. Howard Munk
President
Windmill Health Products, LLC
6 Henderson Drive
West Caldwell, NJ 07006
 

WARNING LETTER

Warning Letter No.: 15-NWJ-01
 

Dear Mr. Munk:

The United States Food and Drug Administration (FDA) conducted an inspection of your firm, Windmill Health Products, LLC, located at 6 Henderson Drive, West Caldwell, NJ, from June 18 through July 17, 2013. The inspection revealed serious 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 111). These violations cause your dietary supplement products 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 (U.S.C.) § 342(g)(1)] in that the products have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements. Our investigator's observations were noted on form FDA-483, lnspectional Observations, which was issued on July 17, 2013.

FDA also reviewed your product labels for Nutri-Betic™ caplets, Vita-betic™ caplets, ProstrinRx™ tablets, Polyflavanol™ capsules, and Glucoflex™ Joint Lube liquid products. Further, FDA reviewed your website at the Internet address www.windmillvitamins.com in July 2013 and again in July 2014 and has determined that you take orders there for the products Nutri-Betic™ caplets, Vita-betic™ caplets, ProstrinRx™ tablets, Polyflavanol™ capsules, and Glucoflex™ Joint Lube liquid. Your product labels and website promote these products for conditions that cause them to be drugs under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims on your product labels and website establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act.

We acknowledge your written responses dated August 7, September 6, October 4, November 7, and December 6, 2013, and January 6, February 6, and March 6, 2014. The agency has reviewed your responses; however, ·the response letters do not address the violations noted below.

You may find the Act and FDA regulations through links on FDA's home page at www.fda.gov.

Unapproved New Drugs

Examples of some of the claims on your product labels that provide evidence that your products are intended for use as drugs include: 

Nutra-Betic ™ caplets
• "Targeted nutritional support for diabetics"
• "[S]cientifically formulated for the specific needs of diabetics."

Vita-Betic™ caplets
• "[T]o meet the dietary needs of diabetics"
• "[T]o meet the nutritional needs of diabetics."

ProstrinRx™ tablets
• "ProstrinRx™ might be the natural solution to BPH (Benign Prostatic Hyperthophy) ... "
• "[C]an help fight BPH and reduce prostate inflammation restoring normal prostate function."
• "[R]elieve the symptoms associated with enlarged prostate and restore healthy function."

Polyflavonol™ capsules
• "[L]ess susceptible to or reducing the intensity of tinnitus."
• "Proven results for ringing in the ears"
• "Stop the ringing"
• "Taken daily, Polyflavonol™ will help you discover the natural way to help reduce the symptoms of tinnitus."
• "You do not have to live with tinnitus any longer!"
• "Help Fight Tinnitus!"

Glucoflex™ Joint Lube liquid
• ""The ingredients in Joint Lube . . . needed for joint repair, help manage pain and inflammation ... " 

Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:

Nutra-Betic™ caplets
• "Supplementing with vitamin C (an ingredient in your product) may benefit people with type 1 diabetes ... including by reducing sorbitol levels, urinary protein loss, glycosylation, and eye damage."
• "Bilberry (an ingredient in your product) may lower the risk of some diabetic complications, such as diabetic cataracts and retinopathy."

Vita-Betic™ caplets
• "Vitamin D (an ingredient in your product) is needed to maintain adequate insulin levels, and supplementing with it may reduce the risk of developing type 1 diabetes."
• "Vitamin E (an ingredient in your product) supplementation may protect against diabetic neuropathy."
• "Biotin (an ingredient in your product) may improve glucose levels and reduce pain from diabetic nerve damage."
• "Magnesium (an ingredient in your product) ... supplementing with the mineral may reduce the risk of ... eye damage and neuropathy."
• "Supplementing with zinc (an ingredient in your product) may lower blood sugar levels and improve immune function in people with Type 1 diabetes."
• "Chromium (an ingredient in your product) has been shown to improve glucose tolerance in people with Type 1 diabetes."

ProstrinRx™ tablets
• "Zinc (an ingredient in your product) has been shown to reduce prostate size in some studies."
• "Saw Palmetto (an ingredient in your product), the leading natural treatment for BPH, has been shown to help keep symptoms in check when used regularly."
• "Men taking Beta-Sitosterol (an ingredient in your product) ... have reported improved BPH symptoms and urinary flow."
• "Nettle (an ingredient in your product) ... may increase urinary volume and flow rate in men with early-stage BPH."

Polyflavonol™ capsules
• "[G]inkgo (an ingredient in your product) may be useful in treating tinnitus."

Glucoflex™ Joint Lube liquid
• "Giucosamine Hydrochloride ... effective at reducing pain and improving symptoms in people with osteoarthritis."
• "Taking glucosamine hydrochloride improved pain in people with rheumatoid arthritis." 

Your Nutri-Betic™ caplets, Vita-betic™ caplets, ProstrinRx™ tablets, Polyflavanol™ capsules, and Glucoflex™ Joint Lube liquid 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 U.S.C. § 321 (p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in section 505(a) of the Act [21 U.S.C. § 355(a)]; see also section 301 (d) of the Act [21 U.S.C. § 331 (d)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. 

Furthermore, your Nutri-Betic™ caplets, Vita-betic™ caplets, ProstrinRx™ tablets, Polyflavanol™ capsules, and Glucoflex™ Joint Lube liquid products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions cannot be written so that a layperson can use them safely for their intended uses. Thus, these drugs are misbranded within the meaning of section 502(f)(1) of the Act, in that their labeling fails to bear adequate directions for use [21 U.S.C. §352(f)(1)]. The introduction of a misbranded drug into interstate commerce is a violation of section 301 (a) of the Act [21 U.S.C. § 331 (a)].

Dietary Supplement CGMP Violations

The inspection revealed significant violations of the CGMP requirements for dietary supplements. These violations cause your dietary supplement products to be adulterated under section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] in that they have been prepared, packed, or held under conditions which do not meet the CGMP regulations for dietary supplements. Additionally, even if your Nutri-Betic TM caplets, Vita-betic™ caplets, ProstrinRx™ tablets, Polyflavanol™ capsules, and Glucoflex™ Joint Lube liquid products did not contain disease claims in their labeling that cause the products to be unapproved new drugs under section 505(a) of the Act [21 U.S.C. § 355(a)], they would still be adulterated dietary supplements within the meaning of Section 402(g)(1) of the Act because they have been prepared, packed, or held under conditions which do not meet the CGMP regulations for dietary supplements. 

Your firm 's processes violate dietary supplement CGMP requirements in the following ways: 

1.    Your quality control personnel failed to ensure that your manufacturing, packaging, labeling, and holding operations ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record, as required by 21 CFR 111.105. Specifically, your quality control personnel failed to verify whether the manufacturers with whom you contract are manufacturing or repackaging products according to specifications. Your firm relies  upon certificates of analysis (COA) from manufacturers with whom you contract in evaluating the potency or composition of your dietary supplement products, but you do not have documentation upon which to establish the reliability of the data that does appear in the COAs, and the COAs lack key information about your products. For example, the COAs for the following lots failed to contain the results of any laboratory assay testing or provided assay results for only limited ingredients: 

• Glucoflex™ Join Lube, packaging lot 6436
• Nutra-Betic™, packaging lot 0112J2
• Vita-Betic™, packaging lot 0241 03
• Polyflavoriol™, packaging lot 0345E2 

Your firm was also unable to provide product specifications, ingredient specifications, or packaging specifications that you use to determine if your products were manufactured and packaged in accordance with your specifications, prior to release for distribution. As a distributor that contracts with other manufacturers to manufacture, package, or label dietary supplements that your firm releases for distribution under your firm's name, your firm has an obligation to know what and how these activities are performed so that you can make decisions related to whether the product conforms to established specifications and whether to approve and release the product for distribution [72 Fed. Reg. 34752, 34790 (June 25, 2007)]. Your firm introduces or delivers, or causes the introduction or delivery, of dietary supplements into interstate commerce for distribution to consumers. As such, your firm has an overarching and ultimate responsibility to ensure that all phases of the production of that product are in compliance with dietary supplement CGMP requirements.

Although your firm may contract out certain dietary supplement manufacturing operations, it cannot, by the same token, contract out its ultimate responsibility to ensure that the dietary supplement it places into commerce (or causes to be placed into commerce) is not adulterated for failure to comply with dietary supplement CGMP requirements (see United States v. Dotterweich, 320 U.S. 277, 284 (1943) (explaining that an offense can be committed under the Act by anyone who has "a responsible share in the furtherance of the transaction which the statute outlaws"); United States v. Park, 421 U.S. 658, 672 (1975) (holding that criminal liability under the Act does not turn on awareness of wrongdoing, and that "agents vested with the responsibility, and power commensurate with that responsibility, to devise whatever measures are necessary to ensure compliance with the Act" can be held accountable for violations of the Act). In particular, the Act prohibits a person from introducing or delivering for introduction, or causing the delivery or introduction, into interstate commerce a dietary supplement that is adulterated under section 402(g) for failure to comply with dietary supplement CGMP requirements (see 21 U.S.C. §§ 342(g) and 331 (a)). Thus, a firm that contracts with other firms to conduct certain dietary supplement manufacturing, packaging, and labeling operations for it is responsible for ensuring that the product is not adulterated for failure to comply with dietary supplement CGMP requirements, regardless of who actually performs the dietary supplement CGMP operations.

We received your response letters, dated August 7, September 6, October 4, November 7, and December 6, 2013, and January 6, February 6, and March 6, 2014, but we find your responses to be inadequate to address this violation. You provided a copy of SOP QC-05.01 Inspection and Testing of Incoming Products; however, you did not provide complete testing records upon which your quality control personnel could have relied to support that specifications were met for identity, purity, and composition for each of the finished products identified above. The documentation you provided also did not contain specification limits for each of the tests performed in order to determine if the finished dietary supplement product specifications have been established and met. Further, there is no evidence that your quality control operations ensured that all required tests and examinations were conducted, as required by 21 CFR 111.110(b), or that your quality control operations reviewed and approved the results of all tests and examinations, as required by 21 CFR 111.110(c).

2.    You failed to establish and follow written procedures for holding and distributing operations, as required by 111.453. Specifically, during the inspection you did not have written procedures which described the requirements for storage, quarantine, and approval of products for distribution. 

We have reviewed your various response letters, in which you provided a copy of SOP G-03.01 Procedure for Holding of Finished· Products. We have reviewed this procedure and find it inadequate because the procedure does not address or cross-reference the following: 

• quarantine requirements to prevent mix-up or contamination of components and product that have been rejected or for which a disposition decision is pending;
• the approval process of components and product in storage;
• the procedure for reserve samples. 

3.    You failed to establish and follow written procedures for product complaints, as required by 21 CFR 111.553. Specifically, your firm lacks written procedures for the review of consumer complaints, the determination of whether the complaint requires further investigation, and the approval of the decision of whether to investigate a product complaint. Additionally, you maintain customer complaint forms, but there is no indication that a qualified person has reviewed or investigated each complaint to determine whether the complaint involved a possible failure of a dietary supplement to meet any of its specifications. Quality Control personnel must review and approve decisions about whether to conduct an investigation regarding a product complaint, and the findings and follow-up action of any investigation performed. When an investigation is completed, you must make and keep records relating to product complaints, in accordance with 21 CFR 111.570. 

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. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.

Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that 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 reinspection 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 facil ity. 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. 

Your response should be addressed to U.S. Food and Drug Administration, 10 Waterview Boulevard, 3rd Floor, Parsippany, New Jersey, 07054, Attn: Kerry Kurdilla, Compliance Officer.

Sincerely,
/S/
Diana Amador-Toro
District Director
New Jersey District

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