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  5. Alopecil Corporation, S.R.L. - 10/16/2014
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WARNING LETTER

Alopecil Corporation, S.R.L. 16/10/2014

Alopecil Corporation, S.R.L. - 10/16/2014


Recipient:
Alopecil Corporation, S.R.L.


United States

Issuing Office:
Center for Food Safety and Applied Nutrition

United States


  

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

Public Health Service
Food and Drug Administration
 College Park, MD  20740 

 

WARNING LETTER
 
OCT 16, 2014 
 
VIA EXPRESS DELIVERY
 
Mr. Leo Medina
President
Autopista 30 de Mayo No. 111
Haina, D.N., Santo Domingo
Dominican Republic
 
Reference No. 431527
 
Dear Mr. Medina:
 
The U.S. Food and Drug Administration (FDA) inspected your processing facility located at Autopista 30 de Mayo No. 111, Haina, D.N., Santo Domingo, Dominican Republic on January 13-15, 2014. The inspection and our review of your product labels revealed serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and regulations. You can find the Act and the regulations through links in FDA’s home page at http://www.fda.gov.
 
At the conclusion of the inspection, our investigator issued an FDA-483. We acknowledge receipt of your e-mail correspondence dated February 14, 2014, July 25, 2014, and August 5, 2014, which included your firm’s corrections to the FDA-483 observations along with supporting documentation. We have reviewed your responses and related documentation and found that your firm has not made adequate corrections, as further described in this letter.  
 
Unapproved New Drug
 
Based on our review of your product label, we have determined that your “Balsamic Honey Syrup” product is promoted for conditions that cause the product to be a drug under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims on your product label establish that the product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering this product for introduction into interstate commerce for such uses violates the Act.
 
Examples of the claims on your product label that provide evidence that your product is intended for use as a drug include:
 
  •  “As with any drug…” under the WARNING statement
  • “Safe and natural ingredients to relieve different symptoms that occur with the flu.”
 
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)]. 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.
 
Adulterated Dietary Supplements: CGMP Violations
 
Your dietary supplement products are adulterated within the meaning of 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 that do not meet the Current Good Manufacturing Practice (CGMP) regulation for dietary supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111).
 
The inspection revealed the following significant violations of the CGMP requirements for dietary supplements:
 
1.    Your firm failed to establish identity specifications for each component that you use in the manufacture of a dietary supplement, as required by 21 CFR 111.70(b)(1). Specifically, you did not have identity specifications for each component used to manufacture your “Watercress, Onion, Radish and Honey Omega 3 Syrup” product.
 
Please note that once you have established the identity specifications for each component, you must verify that the specifications are met in accordance with 21 CFR 111.75(a)(1)(i) and (a)(2), and you must make and keep records in accordance with 21 CFR 111.95(b).
 
We acknowledge that in your response dated February 13, 2014, you provided the descriptions of each of the components of the “Watercress, Onion, Radish and Honey Omega 3 Syrup” product. However, your response is inadequate because the provided descriptions are not adequate identity specifications in that they are not sufficient to identify any material. For example, the onion description does not specify what kind of onion your firm will be using.
 
2.    Your firm failed to qualify suppliers of components other than dietary ingredients by establishing the reliability of the suppliers’ certificates of analysis (COA) through confirmation of the results of the suppliers’ tests or examinations, as required by 21 CFR 111.75(a)(2)(ii)(A). Specifically, during the manufacture of “Watercress and Onion, Radish-Honey Omega 3 Syrup” lot #465, you used various components produced by multiple suppliers and relied on the COAs provided without qualification.
 
We acknowledge that in your response dated February 13, 2014, you indicated that you initiated a process of qualifying suppliers by collecting a supplier data sheet and obtaining COAs. However, your response is inadequate because this is not an appropriate verification method under 21 CFR 111.75(a)(2)(ii)(A). You must qualify your suppliers by performing your own testing to verify the reliability of the data in the suppliers’ COAs.
 
3.    Your firm 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, and for approving or rejecting any reprocessing, as required by 21 CFR 111.103. Specifically, at the time of the inspection, you did not have written procedures for quality control operations.
 
We acknowledge that in your response dated February 13, 2014, you provided quality manual procedures that are under development. However, your response is inadequate because the provided procedures are incomplete and we had not received completed and implemented procedures at the time of issuance of this letter.
 
4.    Your firm failed to prepare a complete batch production record every time you manufactured a batch of dietary supplements as required by 21 CFR 111.255. Specifically, the batch production record for your “Watercress and Onion, Radish-Honey Omega 3 Syrup” product, lot #465, failed to contain the following information for a batch production record, as required in 21 CFR 111.260:
  • The identity of equipment and processing lines used in producing the batch [21 CFR 111.260(b)].
  • A statement of the actual yield and a statement of the percentage of theoretical yield at appropriate phases of processing [21 CFR 111.260(f)].
  • The results of any testing or examination performed during the batch production, or a cross-reference to such results [21 CFR 111.260(h)].
  • The initials of the persons performing each step, including:
The initials of the person responsible for weighing or measuring each component used in the batch [21 CFR 111.260(j)(2)(i)]
The initials of the person responsible for verifying the weight or measure or each component used in the batch [21 CFR 111.260(j)(2)(ii)]
The initials of the person responsible for adding the component to the batch [21 CFR 111.260(j)(2)(iii)]
The initials of the person responsible for verifying the addition of components to the batch [21 CFR 111.260(j)(2)(iv)].
 
We acknowledge that in your response dated February 13, 2014, you provided a revised Batch Production Record form. However, your response is inadequate because the revised form lacks complete information required for a batch production record under 21 CFR 111.260.
 
5.    Your firm failed to establish and follow written procedures for fulfilling the requirements for returned dietary supplements, as required by 21 CFR 111.503. Specifically, you did not have any written procedures for when a returned dietary supplement is received, including procedures for identifying, holding, evaluating, and disposing of returned products. Please note that once you have established such procedures, you must keep records for returned dietary supplements, as required by 21 CFR 111.535(b).
 
We acknowledge that in your response dated February 13, 2014, you provided an “Instruction Work Sheet” for handling returned products. However, your response is inadequate because the provided procedures failed to address all the requirements in 21 CFR 111.503, such as the identification and quarantine of returned dietary supplement (111.510); and when must an investigation be conducted of your manufacturing processes and other batches (111.530).
 
Adulterated Products
 
Your “Limpia Pecho Syrup” product is adulterated under section 402(a)(2)(C)(i) of the Act because it contains an unapproved food additive. Specifically, the “Limpia Pecho Syrup” product contains salicylic acid, which is an unsafe food additive within the meaning of section 409 of the Act.
 
Your “Limpia Pecho Syrup” product is also adulterated within the meaning of section 402(a)(2)(C)(i) of the Federal Food, Drug and Cosmetic Act (the Act) [21 U.S.C. §342(a)(2)(C)(i)]. The product contains sodium saccharin, but the use of sodium saccharin as a food additive is not in conformity with requirements in 21 CFR 180.37 that pertain to required labeling, which is a condition of safe use. The label of any finished product that contains sodium saccharin must bear the name of the additive [21 CFR 180.37(f)(2)(i)], and for processed foods, the amount of sodium saccharin per serving, calculated as saccharin, in terms of the weight or serving size, which shall be the quantity of the food containing 30 milligrams or less of the additive [21 CFR 180.37(f)(2)(ii)(c)].
 
Misbranded Products
 
Even if your “Balsamic Honey Syrup” product did not have therapeutic claims which make it an unapproved new drug, it would still be a misbranded dietary supplement under section 403 of the Act (21 U.S.C. § 343). In addition, your “Arabian Formula Syrup,” “Century 22 Purifier Syrup,” “Limpia Pecho Syrup,” and “Watercress and Onion, Radish-Honey Omega 3 Syrup” products are also misbranded under section 403 of the Act.
 
1.    Your “Limpia Pecho Syrup” product is misbranded within the meaning of section 403(i)(2) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. §343(i)(2)] because it is fabricated from two or more ingredients and each ingredient is not declared on the label, as required by 21 CFR 101.4(b)(2).
 
For example, the formulation sheet for your “Limpia Pecho Syrup” product lists “Extracto Doble Accion” (English Translation: Double Action Extract) as an ingredient, which, according to your explanation, contains vegetable (onion, watercress, and radish) extracts using ethyl alcohol; however, your label fails to declare the sub-ingredients ethyl alcohol and radish.
 
2.    Your “Limpia Pecho Syrup” product is misbranded within the meaning of section 403(a)(1) of the Act because your label uses the term “natural” in a manner that is false and misleading. Your label states “Natural Product” on the principal display panel. FDA considers the use of the term “natural” on a food label to be truthful and non-misleading when “nothing artificial or synthetic…has been included in, or has been added to, a food that would not normally be expected to be in the food.” (58 FR 2302, 2407, January 6, 1993). Your ingredient statement for this product declares various artificial colors. For this reason your product is misbranded within the meaning of section 403(a)(1) of the Act.
 
3.    Your “Limpia Pecho Syrup” product is misbranded within the meaning of section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information is not in an appropriate format. Specifically,
  • The number of servings per container is not rounded to the nearest whole number in accordance with 21 CFR 101.9(b)(8)(i).
  • Trans fat is not declared in accordance with 21 CFR 101.9(c)(2)(ii).
  • Cholesterol is not declared in accordance with 21 CFR 101.9(c)(9).
  • The required footnote is incomplete in accordance with 21 CFR 101.9(d)(9)(i).
 
4.    Your “Arabian Formula Syrup” and “Balsamic Honey Syrup,” products are 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 or labeling of the supplements fails to identify the products by using the term “dietary supplement,” which term may be modified with the name of such an ingredient in the product or an appropriately descriptive term, as required by 21 CFR 101.3(g).
 
5.    Your “Arabian Formula Syrup,” “Balsamic Honey Syrup,” “Century 22 Purifier Syrup,” and “Watercress and Onion, Radish-Honey Omega 3 Syrup” products are misbranded under section 403(y) of the Act [21 U.S.C. § 343(y)] in that the labels fail to include a domestic address or domestic phone number through which the responsible person (as described in section 761 of the Act, 21 U.S.C. § 379aa-1) may receive a report of a serious adverse event with such dietary supplements.
 
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist at your facility and 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. As a manufacturer of dietary supplement products intended for export to the United States, you are required to comply with the U.S. Federal Food, Drug, and Cosmetic Act (the Act) and all applicable federal regulations. 
 
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 foreign facility, FDA will assess and collect fees for reinspection-related costs from the U.S. Agent for the foreign 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 consider providing a copy of this letter to your U.S. Agent.
 
You should respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct these violations and should include documentation that would assist us in evaluating your corrections. Responding in English will assist us in our review of your documentation. If you cannot complete all corrections within 15 days, you should explain the reason for your delay and state when you will correct any remaining violations.
 
If you do not respond to this letter or if we find your response inadequate, we may take further action. For instance, we may take action to refuse admission of your imported dietary supplement products under Section 801(a) of the Act, 21 U.S.C. 381(a), including placing them on detention without physical examination (DWPE). FDA’s DWPE is an administrative procedure whereby products offered for import into the United States may be detained without physical examination upon entry. DWPE information may be conveyed in FDA’s Import Alerts. For your information, an example of an Import Alert that conveys information specific to foreign firms that are not in compliance with the current Good Manufacturing Practices for dietary supplements regulations (21 CFR 111) is Import Alert #54-14; an Import Alert specific to products that are not in compliance with labeling regulations (21 CFR 101) is Import Alert #99-20, and an Import Alert specific to products that are unapproved new drugs promoted in the U.S. is Import Alert #66-41. These alerts can be found on FDA’s web site at: http://www.fda.gov/ForIndustry/ImportProgram/ImportAlerts/default.htm.
 
We note that the formulation sheet for your “Watercress and Onion, Radish-Honey Omega 3 Syrup” product lists “Sacarina Sodica” (sodium saccharin) as an ingredient; however, this ingredient is not listed on the label of the product. If sodium saccharin is used as an ingredient in this product, it must be declared on the label in accordance with the food labeling and food additive requirements.
 
Please send your reply to the U.S. Food and Drug Administration, Attention: Mabel M. Lee, Compliance Officer, Center for Food Safety and Applied Nutrition, Office of Compliance, Division of Enforcement, Labeling and Dietary Supplement Compliance Branch (HFS-608), 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. Please reference #431527 on any submissions and within the subject line of any emails to us. If you have any questions regarding this letter, you may contact Ms. Lee via email at Mabel.Lee@fda.hhs.gov.
 
Sincerely,
/S/ 
William A. Correll, Jr.  
Director
Office of Compliance
Center for Food Safety
     and Applied Nutrition