Inspections, Compliance, Enforcement, and Criminal Investigations
Oza Compound Products, LLC 6/7/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
300 River Place
Detroit, MI 48207
June 7, 2012
Mr. Mark A. Smith
Oza Compound Products, LLC.
1221 Production Road
Fort Wayne, IN 46808
Dear Mr. Smith:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your dietary supplement manufacturing facility located in Fort Wayne, Indiana, from January 18 through January 19, 2012. During the inspection, our investigator found significant violations of the Current Good Manufacturing Practice (CGMP) regulations for dietary supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). These CGMP violations cause your Oza Compound dietary supplement product 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 dietary supplement has been prepared, packed, or held under conditions that do not meet CGMP regulations for dietary supplements. Our investigator's observations were noted on form FDA-483, Inspectional Observations, which was issued to you on January 19, 2012.
In addition, our investigator collected and reviewed samples of the labeling of your dietary supplement product during the inspection of your facility. We also reviewed your website at http://www.ozacompoundproducts.com in March 2012. Based on our review of your product labeling, we have determined that your Oza Compound dietary supplement product is promoted for conditions that cause it to be a drug within the meaning of section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims on your labeling establish that the product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease.
Further, based on our review of your product labels, we have determined that your Oza Compound dietary supplement product is misbranded within the meaning of section 403 of the Act [21 U.S.C. § 343). Regulations implementing the food labeling requirements of the Act are found in 21 CFR Part 101. You may find the Act and the FDA's regulations through links on FDA's home page at http://www.fda.gov.
Dietary Supplement CGMP Violations
The inspection revealed the following violations:
1. Your firm failed to establish the following specifications required by 21 CFR 111.70:
• Identity specifications for each component that you use in the manufacture of a dietary supplement [21 CFR 111.70(b)(1)].
• Component specifications, for each component that you use in the manufacture of a dietary supplement, that are necessary to ensure that specifications of the purity, strength, and composition of dietary supplements manufactured using the components are met [21 CFR 111.70(b)(2)].
• Product specifications for the identity, purity, strength, and composition of the finished batch of dietary supplement for each dietary supplement that you manufacture [21 CFR 111.70(e)].
Specifically, you provided no evidence to demonstrate that you have established the above-mentioned specifications in manufacturing your Oza Compound dietary supplement product. In addition, we note that once you have established the required specifications under 21 CFR 111.70, you must determine whether the specifications have been met [21 CFR 111.73].
We have reviewed your response to the FDA-483 dated February 7, 2012. You stated that you are working to correct the observations of our investigator, but your response is inadequate because you failed to specify any corrective action that you would take to address these violations.
2. Your firm's batch production records (BPRs) for your Oza Compound dietary supplement product failed to include complete information relating to the production and control of each batch and the information required to be included in a batch record, as required by 21 CFR 111.255(b) and 21 CFR 111.260. Specifically, your BPRs did not include the following required information:
• The identity of equipment and processing lines used in producing the batch [21 CFR 111.260(b)];
• 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 [21 CFR 111.260(c)];
• The actual results obtained during any monitoring operation [21 CFR 111.260(g)];
• The results of any testing or examination performed during the batch production, or a cross-reference to such results [21 CFR 111.260(h)];
• Documentation that the finished dietary supplement meets specifications established in accordance with 21 CFR 111.70(e) and (g) [21 CFR 111.260(i)];
• Documentation, at the time of performance, of the manufacture of the batch, including the initials of the persons performing each step in the master manufacturing record (MMR) [21 CFR 111.260(j)(2)]. Specifically, the BPR did not include:
- The initials of the persons responsible for weighing or measuring each component used in the batch (21 CFR 111.260(j)(2)(i));
- The initials of the persons responsible for verifying the weight or measure of each component used in the batch [21 CFR 111.260(j)(2)(ii)];
- The initials of the persons responsible for adding the component to the batch [21 CFR 111.260(j)(2)(iii)]; and
- The initials of the persons responsible for verifying the addition of components to the batch [21 CFR 111.260(j)(2)(iv)].
• Documentation of quality control personnel's review of any monitoring operations such as the results of any tests and examinations, including tests and examinations conducted on components, in-process materials, finished batches of dietary supplements, and packaged and labeled dietary supplements [21 CFR 111.260(1)].
We have reviewed your response to the FDA-483 dated February 7, 2012, which included updated Manufacturer's Worksheets that you use as BPRs. Your response is inadequate because you did not address the specific items above.
3. Your firm's MMR for your Oza Compound dietary supplement product failed to identify specifications for the points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in your MMR, as required by 21 CFR 111.205(b)(1). Your firm 's MMR for this product failed to include the following information required by 21 CFR 111.210:
• Corrective action plans for use when a specification is not met [21 CFR 111.210(h)(5)].
We have reviewed your response to the FDA-483 dated February 7, 2012, which included updated Manufacturer's Worksheets that you use as a MMR. Your response is inadequate because you did not address the specific items above.
4. Your firm failed to establish written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision, and for approving or rejecting any reprocessing, as required by 21 CFR 111.103. Specifically, you provided no written procedures for quality control operations.
We have reviewed your response to the FDA-483 dated February 7, 2012. You stated that you are working to correct the observations of our investigator, but your response is inadequate because you failed to specify any corrective action that you would take to address this violation.
Unapproved New Drug
5. During the inspection at your facility, our investigator collected labels associated with your Oza Compound dietary supplement product. In addition, we reviewed your website at http://www.ozacornpoundproducts.com in March 2012. Based on our review of your product labeling, we have determined that your product is promoted for conditions that cause it to be a drug within the meaning of section 201(g)(1)(B) of the Act (the Act). The therapeutic claims in your labeling establish that the product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of this dietary supplement product with these claims violates the Act.
Examples of some of the claims observed in your product labeling include:
• "Vitamin B3 (Niacin): ... has been used to treat and eliminate cancer cells. It also lowers cholesterol, in large does [sic]."
• "Cold and Flu Eliminator"
• "It helps to build up the bodies blood and allow one's own immune system to help fight off colds, flues, and various other ailments associated with the body."
Examples of some of the claims observed on your website include:
• "Back in 2005 I had 2 miscarriages ....I was willing to try anything to help ... During the next few years after taking Oza Compound, I had 3 children that came to term ... Then in 2008 I decided to stop using Oza Compound .... Well, within a year and a half I had another miscarriage again. After that I decided to get back to using Oza Compound, and now I am pregnant with my fourth child."
• " ...I came down with a bad case of Mono .... Here comes my dad, "You need to take Oza Compound, and take it right. DO NOT skip a dose!" ... I took it 3 times a day, everyday. A week later I was cured."
• "We started using Oza Compound because we all had whooping cough and were desperate to try anything to get rid of the symptoms. A friend of mine recommended it and said that Oza Compound could help us get over it. My husband, my 3 children, my younger brother and myself used it and I feel that it lessened the severity of the illness. My brother did not have whooping cough at the time, but he took Oza Compound anyway to keep from getting whooping cough from us. We notice a difference in how we felt in a matter of a few days; we had less mucus and it was easier to move it out of the body. It took about 6 weeks to run its course but the symptoms were not as bad as I believe they would have been had we not used Oza Compound. Right now, we all use Oza Compound when we start to feel congested or if we start to get a little in the back of our throats and are trying to beat off any illnesses."
• "I've had sinus problems almost all my life. It was until I got pregnant that it got much worse. I've heard that Oza Compound was a good general health tonic to take for a wide assortment of problems, so I thought I would give it a try. After a little over a month I started to feel much better."
• "When I took over the business in 2004, I decided to take it every day, and I have to tell you, I don't get sick all that much, my allergies aren't as bad .. "
• "Back in 1990 my daughter, who was 6 years old at the time, stated having a lot of trouble with sore throats and sickness. Having read about Oza Compound from the newspaper, I decided to give it a try. Within a couple of months, I could see a difference."
• "About 6 years ago I came down with Mono and felt pretty tired and was very sick. Within a couple of weeks, after using Oza Compound, I was cured of my mono."
• "After my 5 year old had his tonsils out, he complained of sores in this mouth. We decided to give him Oza Compound to see if it would help. After about 2 months he started feeling a lot better and the sores slowing went away."
Your product is not generally recognized as safe and effective for the above-referenced uses and, therefore, the product is a "new drug" under section 201 (p) of the Act, [21 U.S.C. § 321(p)(1)]. 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 U.S.C. § 355(a)]. 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.
We have reviewed your response to the FDA-483 dated February 7, 2012, indicating that you will revise your current label by blacking out the testimonial with a permanent marker. Your proposed reconditioning is inadequate because your firm does not have adequate packaging and labeling controls to ensure that all product labels will be blacked out. In addition, your response is inadequate because it failed to address the personal testimonials on your website that establish the intended use of your product as a drug.
Misbranded Dietary Supplement
6. Your Oza Compound dietary supplement product is misbranded within the meaning of section 403(s)(2)(B) of the Act [21 U.S.C. §343(s)(2)(B)] in that the label fails to identify the product using the term "dietary supplement" in accordance with 21 CFR 101.3(g), which requires that a dietary supplement be identified by the term "dietary supplement" as part of the product's statement of identity, except that the word "dietary" may be deleted and replaced by the name of the dietary ingredient in the product.
7. Your Oza Compound dietary supplement product is misbranded within the meaning of section 403(s)(2)(A) of the Act [21 U.S.C. §343(s)(2)(A)] in that the label fails to list the name of each ingredient of the supplement that is described in section 201(ff) and the quantity of each such ingredient. For example, your labeling contains ingredient information to suggest that your product contains an herb or other botanical ingredient which is an extract from the bark of oak trees.
You do not list this botanical ingredient and you do not list the quantitative amount by weight per serving in the Supplement Facts panel in accordance with 21 CFR 101.36(b)(3)(i) and (ii).
8. Your Oza Compound dietary supplement product is misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. §343(q)(5)(F)]. Your product contains Potassium Sorbate, but potassium and its quantitative amount by weight per serving is not listed in the Supplement Facts panel. In accordance with 21 CFR 101.36(b)(2)(i), vitamins or minerals listed in 21 CFR 101.9(c)(8)(iv) or (c)(9) must be declared when they are added to the product for purposes of supplementation, or when a claim is made about them. Because you list Potassium Sorbate in your "other ingredients," you are making a claim about the presence of potassium in your product, and therefore potassium and its quantitative amount by weight per serving must be listed in the Supplement Facts panel.
Under 21 CFR 101.36(b)(2)(iii), the percent of the daily value must be declared for all dietary ingredients for which FDA has established daily values. Specifically, the label of your Oza Compound dietary supplement product lists incorrect percent daily values for all dietary ingredients in your product based on the established RDI. The RDI's for each of the dietary ingredients can be found in 21 CPR 101.9(c)(8)(iv). For example, the RDI for iron is 18 mg, but you incorrectly list the % Daily Value as 683% based on an amount per serving of 41 mg.
The product label lists ingredients such as Filtered water and Alum inside the Supplement Facts panel. Under 21 CFR 101.4(g), these ingredients must be listed outside of the Supplement Facts panel. 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). You also list other information, including directions for use, serving levels for children and adults, and a statement about discoloration, within the Supplement Facts box which is not in accordance with 21 CFR 101.36.
The above violations are not an all-inclusive list of violations at your facility. It is your responsibility to ensure that your establishment and your products comply with the Act and its implementing regulations. You should take prompt action to correct the violations addressed in this letter. We advise you to review your website, product labels, and other labeling and promotional materials for your product to ensure that the claims you make for your product do not cause it to violate the Act.
You should take prompt action to correct the violations cited in this letter and prevent their recurrence. Failure to do so may result in enforcement action by FDA without further notice, including seizure and/or injunction.
In addition to the above violations, we have the following comment:
• The names of some of the dietary ingredients listed in the Supplement Facts panel are not listed according to the nomenclature specified in 21 CFR 101.9 or in 21 CFR 101.36(b)(2)(i)(B)(2), and they are not listed in their correct order in accordance with 21 CFR 101.36(b)(2)(i)(B).
Within fifteen (15) working days from your receipt of this letter, please notify this office in writing of the specific steps you have taken to correct all of the violations described above. Include in your response documentation to show that correction has been achieved. If you cannot complete all corrections within 15 working days, please state the reason for the delay and the date by which you will complete the corrections.
Please send your written reply to this letter to Cicely N. Vaughn, Compliance Officer, U.S. Food and Drug Administration at 300 River Place, Suite 5900 Detroit, MI 48207.
If you have any questions about this letter, please contact Compliance Officer Vaughn at 313-393-8297.
Detroit District Office