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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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American Natural Products Inc 5/2/13

  

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 

 

VIA UPS
w/ DELIVERY CONFIRMATION
 
WARNING LETTER
FLA-13-19
 
May 2, 2013
 
Mr. Rodolfo Cruz
President and Co-Owner
American Natural Products, Inc
7350 NW 7th Street, Suite 101
Miami, FL 33126
 
Dear Mr. Cruz:
 
The United States Food and Drug Administration (FDA) conducted an inspection of your dietary supplement manufacturing facility located at 7350 NW 7th Street, Suite 101, Miami, Florida from September 17 to September 20, 2012. During the inspection, our investigators found significant violations of Title 21 of the Code of Federal Regulations, Part 111, Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements. 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 dietary supplements have been prepared, packed, or held under conditions that do not meet CGMP regulations for dietary supplements. You may find the Act and FDA’s regulations through links in the FDA’s home page at www.fda.gov.    
 
The inspection revealed the following violations:
 
  1. You did not conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient prior to its use, as required by 21 CFR 111.75(a)(1)(i), nor has FDA received a petition from you, and granted the petition, to exempt you from this testing requirement, pursuant to 21 CFR 111.75(a)(1)(ii).  Specifically, the following products and batches lacked necessary identity testing to verify components that are dietary ingredients:
 

Product
Dietary Ingredients
Batch #s
Milk Thistle
Milk Thistle
460412, 190511, 400810
Artrimax
Vitamin D, Calcium Carbonate, Glucosamine Sulfate, Chondroitin Sulfate, Boswellia Serrata
590812, 590312, 230711

 
We reviewed your response letter, dated October 9, 2012, and determined your response to be inadequate. You state in your letter that you have “contacted (b)(4) to send Raw Material Samples for analysis and thus begin the suppliers’ qualification. The correspondent document for qualification of Suppliers will be written as part of the needed documentation for Quality Control.”  This response is inadequate, as 21 CFR 111.75(a)(1) does not permit you to rely on a supplier’s qualification to verify the identity of components that are dietary ingredients.
 
  1. You failed to confirm the identity of components that are not dietary ingredients and determine whether other applicable component specifications established in accordance with 21 CFR 111.70(b) are met, as required by 21 CFR 111.75(a)(2). This requirement may be met by either conducting appropriate tests or examinations, per 21 CFR 111.75(a)(2)(i); or by relying on a certificate of analysis (COA) from the supplier of the component that you receive, provided that, among other requirements, you first qualify your component suppliers by establishing the reliability of the suppliers’ COA through confirmation of the results of the suppliers’ tests or examinations, per 21 CFR 111.75(a)(2)(ii)(A).  Specifically, you did not conduct appropriate tests or examinations or qualify your suppliers of the components used for the following products and batches:
 

Product
Non-Dietary Ingredients
Batch #s
Milk Thistle
Rice
460412, 190511, 400810
Artrimax
Rice
590812, 590312, 230711

 
We reviewed your response letter, dated October 9, 2012, and determined your response to be inadequate. You state in your letter that you have “contacted (b)(4) to send Raw Material Samples for analysis and thus begin the suppliers’ qualification. The correspondent document for qualification of Suppliers will be written as part of the needed documentation for Quality Control.” This response is inadequate because you provided no documentation of the qualification program to verify that incoming components meet the established specifications, no documentation that the specifications established in accordance with 21 CFR 111.70(b) are met, and no timeline for implementing such a program.
 
  1. You failed to establish the following specifications as required by 21 CFR 111.70:

 

  • A specification for any point, step, or stage 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 the master manufacturing record (MMR) [21 CFR 111.70(a)];
  • Component specifications for each component used in the manufacture of a dietary supplement, including:
 
o   Identity specifications [21 CFR 111.70(b)(1)],
o   Specifications to ensure the purity, strength and composition of the dietary supplements manufactured using these components [21 CFR 111.70(b)(2)], and
o   Specifications that establish the 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 [21 CFR 111.70(b)(3)];
 
  • Specifications for dietary supplement labels (label specifications) and for packaging that may come into contact with your dietary supplements, as required by 21 CFR 111.70(d).
 
Specifically, you confirmed to our investigator that your firm does not have specifications for the manufacturing process for your dietary supplement products, that your firm does not have specifications for each dietary ingredient component that you use in the manufacture of a dietary supplement, and that your firm does not have documented, established specifications for incoming labeling and packaging component. 
 
We have reviewed your response letter, dated October 9, 2012, and have determined your response to be inadequate. Your letter states, “As part of the documentation is the establishment of the specifications of products. Our Company has signed a contract with (b)(4).  In order to send Finished Product Samples for analysis. Our Company has also decided to acquire the necessary laboratory equipments to control the manufacturing process.” However, you have not provided documentation of any product specifications that you have established to ensure the quality of your dietary supplements and no timeline for when the specifications will be implemented.
 
Further, we note that, once you establish specifications, you must verify that specifications are met, in accordance with 21 CFR 111.73 and 21 CFR 111.75.
 
  1. You failed to establish an MMR in accordance with 21 CFR 111.205. You do not prepare and follow a written MMR for each unique formulation of dietary supplement your firm manufactures, and for each batch size, to ensure uniformity in the finished batch from batch to batch, as required by 21 CFR 111.205(a). You also do not prepare and follow an MMR that identifies 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 the MMR, as required by 21 CFR 111.205(b)(1). Specifically, you did not establish a written MMR that satisfies the requirements of 21 CFR 111.210 for batches 460412, 190511, and 400810 of your Milk Thistle product.
 
We have reviewed your response letter, dated October 9, 2012, and have determined the response to be inadequate. You state in your letter that you intend to complete a written MMR for your products, but you have not provided a timeline for the completion of the record or documentation of what the MMR will contain.
 
  1. You failed to perform required quality control operations to ensure that your manufacturing, packaging, labeling, and holding operations ensure the quality of the dietary supplement, and that your dietary supplement products are packaged and labeled as specified in the MMR, as required by 21 CFR 111.105. Additionally, you failed to establish and follow written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision, as required by 21 CFR 111.103. Specifically, you do not have any processes, specifications, written procedures, tests, or examinations that have been reviewed and approved by quality control, nor have you established written procedures for quality control personnel to follow.
 
We have reviewed your response letter, dated October 9, 2012, and have determined your response to be inadequate. You state in your letter that you have acquired a quality control technician “to implement Quality Control Operations for approving or rejecting all procedures, methods, documentation, and specifications impacting on the identity, strength, composition, and purity of the dietary supplement products.” However, you provided no specific information about the quality control procedures that the quality control technician must follow or specifications that the quality control technician must verify, such as product specifications to ensure the quality of your dietary supplements (21 CFR 111.70(a)), finished product specifications (21 CFR 111.70(e)), or what finished product testing is needed to verify that your finished batch of dietary supplement meets product specifications for identity, purity, strength, composition, and for limits on those types of contaminants that may adulterate or lead to adulteration of the finished batch (21 CFR 111.75(c)).
 
  1. Your batch production records (BPR) for your dietary supplement products do not include complete information relating to the production and control of each batch, as required by 21 CFR 111.255(b). You confirmed to our investigator that you create BPRs by looking at an MMR and then adjusting the amounts to create the desired batch size. Your BPRs do not contain the required information under 21 CFR 111.260, including, among other requirements:
 
    • The batch, lot, or control number of the finished batch of dietary supplement [21 CFR 111.260(a)(1)];
    • 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 identity and weight or measure of each component used [21 CFR 111.260(e)];
    • 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 at the time of performance of any required material review and disposition decision [21 CFR 111.260(m)].
 
Specifically, you did not establish batch production records in accordance with 21 CFR 111.260 for the following products:
 
a)      three batches (460412, 190511, and 400810) of your Milk Thistle product;
b)      three batches (590812, 590312, and 230711) of your Artrimax product.
 
  1. You failed to establish and follow written procedures for laboratory operations, including written procedures for the tests and examinations that you conduct to determine whether specifications are met, as required by 21 CFR 111.303. You also failed to make and keep records for your laboratory operations in accordance with the Records and Recordkeeping regulations in 21 CFR Part 111, as required by 21 CFR 111.325.
 
  1. You failed to establish and follow written procedures for packaging and labeling operations, as required by 21 CFR 111.403. You also failed to make and keep records of the written procedures for packaging and labeling operations, as required by 21 CFR 111.430(b).
 
  1. You failed to establish and follow written procedures for holding and distributing operations, as required by 21 CFR 111.453. You also failed to make and keep records for written procedures for holding and distribution operations and records of product distribution, as required by 21 CFR 111.475(b).
 
This letter is 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. Failure to promptly correct the violations specified above may result in enforcement action without further notice, including, without limitation, seizure and injunction.
 
In addition, we have the following comments:
 
  • Your firm assigns an expiration date of three years from the date of packaging of your products. Specifically, you stated that a three year expiration date was used because 20 years ago that was the standard when the firm first entered into the business. Any expiration date you place on a product label should be supported by data that demonstrates the product’s shelf life [See 72 Fed. Reg. 34752, 34856 (Jun. 25, 2007)].
 
  • Your Milk Thistle and Artrimax product labels do not declare all ingredients that are present in the products. Neither product lists the non-dietary ingredient rice in the ingredient statement, as required by 21 CFR 101.4(a)(1).
 
Please notify this office in writing within 15 working days from your receipt of this letter. Your response should include the specific steps you have taken to correct the violations noted above and to ensure that similar violations do not occur. Your response should include any documentation necessary to show that correction has been achieved. If you cannot complete all corrections before you respond, state the reason for the delay and the date by which you will complete the corrections.
 
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 non-compliance 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 facility. The inspection noted in this letter identified non-compliance materially related to a food safety requirement of the Act.  Accordingly, FDA may assess fees to cover any costs related to reinspection.
 
Your response should be sent to:
 
Food and Drug Administration
Florida District Office
555 Winderley Place, Suite 200
Maitland, FL 32751
 
If you have any questions about the content of this letter, please contact Dr. Andrea Norwood, Compliance Officer, at (407) 475-4724.
 
Sincerely,
/S/
Emma R. Singleton
Director, Florida District