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U.S. Department of Health and Human Services

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Enforcement Actions

Naturavit, Inc. 8/27/12

  

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

Public Health Service
Food and Drug Administration
 

Florida District
555 Winderley Place, Suite 200
Maitland, Florida 32751
Telephone: 407-475-4700
FAX: 407-475-4770

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

WARNING LETTER

FLA-12-43

August 27, 2012

Mrs. Evangelia I. Amyradakis
President
Naturavit, Inc.
10961 S.W. 120th Street
Miami, FL  33176-4532

Dear Mrs. Amyradakis:

On February 27, February 29, and March 2, 2012, the U.S. Food and Drug Administration (FDA) conducted an inspection of your facility, located at 10961 S.W. 120th Street, Miami, FL 33176-4532.  The inspection revealed serious violations of FDA’s Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111).  At the conclusion of the inspection, you were issued a Form FDA 483, Inspectional Observations, which listed a number of the violations that 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 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. 

In addition, FDA collected and reviewed samples of the labels of your dietary supplement products during the inspection of your facility.  Based on our review of your product labels we have determined that your products Noni Imperial Hawaiian, Garlic & Parsley, Cholestol, Nopal, and Diatrin are promoted for conditions that cause them to be drugs 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 labels establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease.  The marketing of these products with these claims violates the Act.

You can find the Act and its implementing regulations through links on FDA’s home page at http://www.fda.gov

The inspection revealed violations including the following:

Adulterated Dietary Supplements

1. You did not prepare and follow a written master manufacturing record for each unique formulation of a dietary supplement that you manufactured as required by 21 CFR 111.205(a).  Specifically, on 2/29/12, you were unable to provide a master manufacturing record for your Liquid Collagen, 16 fl. oz. product.  Additionally, on 2/27/12, you stated that you did not have master manufacturing records for your firm’s dietary supplement products.

We have reviewed your response dated March 31, 2012 and have found it to be inadequate.  Your response indicates that you are seeking clarification regarding the nature of this violation. The requirement to prepare and follow a written Master Manufacturing Record in the packaging and labeling of your dietary supplement products is a basic requirement.  If you do not understand this requirement, you may wish to seek assistance from a consultant or pursue training in this area.

2. You did not prepare a batch production record every time you manufactured a batch of dietary supplements as required by 21 CFR 111.255(a).  Specifically, on 2/29/12, you were unable to provide a batch production record for your Liquid Collagen, 16 fl. oz. product.  Additionally, on 2/27/12, you stated that you do not make batch records for your firm’s dietary supplement products.

We have reviewed your response dated March 31, 2012 and have found it to be inadequate.  Your response indicates that you are seeking clarification regarding the nature of this violation. The requirement to prepare batch production records every time you manufacturer a batch of your dietary supplement products is a basic requirement.  If you do not understand this requirement, you may wish to seek assistance from a consultant or pursue training in this area.

3. You have not identified personnel to be responsible for your quality control operations as required by 21 CFR 111.12(b). You have also not established 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 and 21 CFR 111.140(b)(1), nor have you documented the implementation and performance of any such quality control procedures as required by 21 CFR 111.140.

We have reviewed your response dated March 31, 2012 and have found it to be inadequate.  Your response indicates that you are seeking clarification regarding the nature of this violation. The requirement to identify personnel responsible for quality control operations and establish written procedures describing the responsibilities of the quality control operations is a basic requirement.  If you do not understand these requirements, you may wish to seek assistance from a consultant or pursue training in this area. 

4. You did not conduct appropriate tests or examinations or rely on a certificate of analysis to determine whether components met established specifications as required by 21 CFR 111.75(a)(2). Specifically, on 2/29/12, the FDA Investigator observed the holding of Hydrolyzed Gelatin, lot # 20110810, to be given to your contract manufacturer for the production of a dietary supplement product. The certificate of analysis you provided the investigator for that lot of Hydrolyzed Gelatin was incorrect in that it was for lot # 20110710. Additionally, there were no records to show that you had conducted testing for the ingredient, and on 2/27/12, you stated that you did not receive a certificate of analysis (COA) for each component.  Furthermore, as required by 21 CFR 111.75(a)(2)(ii)(A), in order to rely on a certificate of analysis from the supplier of a component, you must first qualify the supplier by establishing the reliability of the supplier’s certificate of analysis.  However, on 2/27/12, you stated that you did not qualify your firm’s suppliers prior to relying on the certificates of analysis they provide in the manufacture of your dietary supplement products.

In your response letter dated March 31, 2012, you provided a copy of the COA for hydrolyzed gelatin, lot # 20110810.  However this response is inadequate in that you failed to indicate how future shipments of components will be handled. Therefore, your response fails to address the underlying requirement that appropriate tests or examinations are performed and/or certificates of analyses from a properly qualified vendor are relied upon to determine if established component specifications are met.  Additionally, your response does not address qualification of your firm’s suppliers.

5. You did not make and keep records of the written procedures for labeling operations as required by 21 CFR 111.430(b).  Specifically, on 2/29/12, the FDA Investigator observed the labeling of Liquid Collagen, 16 fl. oz., lot # 6126, Exp. 1/15.  You were unable to provide written procedures for labeling operations.  Additionally, on 2/27/12, you stated that you did not make written procedures or records for the firm’s labeling operations.

In your response letter dated March 31, 2012, you provided labeling procedures.  However, the response is inadequate in that the labeling procedures do not address all of the applicable requirements under 21 CFR Part 111, Subpart L.  For example, the procedures do not address the control of the issuance and use of packaging and labels, and reconciliation of any issuance and use discrepancies, as required by 21 CFR 111.410(b).  While reconciliation is not required for cut or rolled labels if a 100% examination for correct labeling is performed by appropriate electronic or electromechanical equipment during or after the finishing operation, your response fails to provide such procedures. 

6. You did not make and keep written procedures for holding and distributing operations, nor did you make and keep records of product distributed, as required by 21 CFR 111.475(b). Specifically, on 2/29/12, you were unable to provide to the FDA Investigator written procedures or distribution records for the holding and distribution of your products in inventory, such as your L-Carnitine, X-Press Loss, Power 10, and Hydrolyzed Gelatin. Additionally, on 2/27/12, you stated that you do not make written procedures or records for the firm’s holding and distribution operations.

In your response letter dated March 31, 2012, you provided holding and distribution procedures.  However, the response is inadequate in that it failed to address holding and distribution requirements for components, packaging, labeling and reserve samples of dietary supplements as required by 21 CFR 111.455 and 21 CFR 111.465.

7. You did not establish and follow written procedures for the review and investigation of product complaints to fulfill the requirements of 21 CFR Part 111, Subpart O, as required by 21 CFR 111.553.  Specifically; on 2/27/12, you were unable to provide to the FDA Investigator written procedures for the review and investigation of dietary supplement complaints and you stated that your firm does not have written procedures.

We have reviewed your response dated March 31, 2012 and have found it to be inadequate. You provided complaint handling procedures which are not adequate because there is no indication of how product complaints will be reviewed and investigated for possible failures of a dietary supplement to meet any of its specifications or other requirements that, if not met, may result in a risk of illness or injury as required by 21 CFR 111.560(a), nor does it address the need for a quality control person to review and approve the decisions about whether to investigate a product complaint and review and approve the findings and any follow-up action, as required by 21 CFR 111.560(b).

8. You did not establish and follow written procedures for when a returned dietary supplement is received to fulfill the requirements of 21 CFR Part 111, Subpart N, as required by 21 CFR 111.503.  Specifically, on 2/27/12, you were unable to provide written procedures for returned dietary supplements and you stated that your firm does not have written procedures other than the return policy listed on your website, which is a 30 day money back guarantee.

We have reviewed your response dated March 31, 2012 and have found it to be inadequate. You provided returned product procedures which are not adequate because your response does not address the requirements of 21 CFR Part 111, Subpart N.  For example, it does not address the need for a quality control person to conduct a material review and make a disposition decision about returned dietary supplements, as required by 21 CFR 111.510.

9. You did not make and keep records documenting the training of your personnel to demonstrate that personnel engaged in labeling and holding of your dietary supplements  have the education, training, or experience to perform the person’s assigned functions as required by 21 CFR 111.14 and 21 CFR 111.12(c).  Specifically, your firm failed to provide documentation to demonstrate that all operators possess the knowledge, training and experience to perform their duties.

We have reviewed your response dated March 31, 2012 and have found it to be inadequate.  Your response indicated that you searched FDA’s website and were unable to find relevant materials.  You may wish to contact a consultant or seek other means of obtaining appropriate training for your firm.

10. You did not collect and hold reserve samples of packaged and labeled dietary supplements that you distributed as required by 21 CFR 111.83(a).  Specifically, you were unable to provide reserve samples for dietary supplement products your firm has distributed.  Additionally, on 2/27/12 you stated that your firm does not collect and hold reserve samples.

In your response letter dated March 31, 2012, you stated that you will hold reserve samples from now on.  We will verify the adequacy of this correction respecting future dietary supplements distributed by your firm during our next inspection.

11. You did not hold dietary supplements under appropriate conditions of temperature, humidity, and light so that their identity, purity, strength, and composition are not affected, as required by 21 CFR 111.455(a).  Specifically, on 2/29/12, the FDA Investigator observed dietary supplements including Artix-1 and Sleep Nice being held at your firm, which is a garage, that were not controlled for exposure to the high temperatures and humidity of Southern Florida.  This condition is inconsistent with the labeling for these products that states in part, “***store***controlled room temperature of 59°-86°F***”.

In your response letter dated March 31, 2012, you stated, “The total of 7 bottles was there momentarily, it will not happen again.”  Your response is inadequate because you did not provide any supporting documentation of a corrective action.

Unapproved New Drugs

Examples of some of the claims observed on your product labels include: 

Noni Imperial Hawaiian

• ”Noni could be used in the treatment of diabetes, gastric ulcers, arthritis, heart disease, high blood pressure, kidney disorder, and also for pain relief.” 

Garlic & Parsley

• “Garlic is used to maintain…blood pressure, lower cholesterol…treatment of asthma, arthritis, cold, flu and ulcers.”

Cholestol

• “***to help fight bad cholesterol; … to avoid all the risks associated with having high levels of this substance in our bodies***”

Nopal

• Nopal…to relieve gastric ulcers…may help those who suffer from diabetes.”

Diatrin

• “Diatrin may help regulate to a healthy blood sugar levels, … enhance the regeneration of pancreatic B cells…”

Because your products, listed, above, are not generally recognized as safe and effective for the above referenced uses, they are “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)].  New drugs 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. 

Furthermore, because your Noni Imperial Hawaiian, Garlic & Parsley, Cholestol, Nopal, and Diatrin products are offered for conditions that are not amenable to self-diagnosis, and treatment by individuals who are not medical practitioners, adequate directions for use cannot be written so that a layperson can use the products safely for their intended uses. Thus, these products are also misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], in that the labeling for these drugs fails to bear adequate directions for use.

The violations mentioned in this letter are not intended to be an all-inclusive list of violations at your facility.  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 promptly correct these violations may result in legal action, without further notice, including, but not limited to, seizure and/or injunction.

Additional Comments:

We further note the following comment regarding the holding of your dietary supplements. 

1. We note that you must hold dietary supplements under conditions that do not lead to mix-up, contamination, or deterioration, as required under 21 CFR 111.455(c).  However, the following was observed during the inspection of your facility:

• On 2/29/12, the FDA Investigator observed dietary supplements at your storage location that were stored in a manner that could lead to mix-up due to the fact that they were unlabeled.

• On 2/27/12, the FDA Investigator observed a bottle of chemical adhesive remover stored directly above finished dietary supplement products ready for distribution.

• On 2/27/12, the FDA Investigator observed a tube of caulking stored in direct contact with the labeling machine loaded with labels used for operations on 2/29/12.

In your response letter dated March 31, 2012, you stated that all boxes are now labeled externally to avoid mix-ups.  However, this response does not address the storage and labeling of boxes, nor does it address storage of chemicals in the facility.

You should respond in writing within fifteen (15) business days from your receipt of this letter.  Your response should outline the specific steps you are taking to correct the violations noted above.  You should include in your response, documentation and any other useful information that would assist us in evaluating your corrections.  If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.

Please send your written reply to the Food and Drug Administration, Attention: Andrea Norwood, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, Florida, 32751.  If you have questions regarding any issues in this letter, please contact Ms. Norwood at (407) 475-4724.
      
Sincerely,

/S/

Emma R. Singleton
Director, Florida District