- Gialive SA de CV
- Issuing Office:
- Center for Food Safety and Applied Nutrition
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||College Park, MD 20740 |
AUG 28, 2015
VIA EXPRESS MAIL
Edgar Arroyo Gonzalez
General Director and Legal Representative
Gialive SA de CV
Carretera a Zacatecas km # 8
Col. TALAMANTES PONCE
Aguascalientes, Aguascalientes Mexico 20311
Dear Mr. Gonzalez:
From January 26-28, 2015, the United States Food and Drug Administration (FDA) conducted an inspection of your manufacturing facility located at Carretera a Zacatecas km # 8, Col. TALAMANTES PONCE, Aguascalientes, Aguascalientes Mexico. Based on our inspection and review of your product labeling collected during the inspection and our subsequent review of your firm’s website, www.gialive.com, we have found serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. You may find the Act and FDA regulations through links on FDA’s website at www.fda.gov
Unapproved New Drugs/Misbranded Drugs
Based on our review of your products’ labeling and website, we have determined that several of your firm’s dietary supplements are being promoted for conditions that cause them to be drugs within the meaning of Section 201(g)(1)(B) of the Act [21 United States Code (U.S.C.) § 321(g)(1)(B)]. The claims made on your products’ labeling and website establish that the products are drugs because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Introducing or delivering these products for introduction into interstate commerce for such uses violates the Act.
The claims observed on your products’ labeling include, but are not limited to, the following from your website, www.gialive.com:
On the Frequently Asked Questions page:
“WHAT IS PROTENGIA?
...It … promotes the creation of essential neurotransmitters to reduce or prevent muliesclerosis [sic], high levels of cholesterol…”
The patent number for the ingredient “PROTENGIA” is referred to on the labels for your AC-H, AC-M, ASD Complex, BLZ, CPX, CV, DC, NT, OM-3 Golden and RG products.
These products are not generally recognized as safe and effective for the above referenced uses and, therefore, these 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 AC-H, AC-M, ASD Complex, BLZ, CPX, CV, DC, NT, OM-3 Golden and RG products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes. Thus, these drugs are misbranded within the meaning of section 502(f)(1) of the Act, in that the 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)].
Adulterated Dietary Supplements
Even if your CV product did not have therapeutic claims which make it a drug, this product manufactured by your firm is adulterated within the meaning of Section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] in that this product has been prepared, packed, or held under conditions that do not meet Current Good Manufacturing Practice (CGMP) requirements for dietary supplements, Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111).
At the close of our inspection, you were advised of these issues in the issued Form FD-483, Inspectional Observations. We received your May 11, 2015, written response to the Form FDA 483 addressing the observations made during the inspection. That response is inadequate to address the observations. We are unable to evaluate the adequacy of your proposed corrective actions for each of the violations because the documentation of examples of your corrective actions did not appear to directly address the violations, nor did you provide us with a timeline for correction.
Our inspection revealed the following violations:
1. Your firm’s quality control operations failed to review and approve all master manufacturing records and batch production records prior to using them in the manufacture of dietary supplements, as required by 21 CFR 111.123(a)(1) and 21 CFR 111.123(a)(2).
2. Your firm failed to establish an identity specification for each component that you use in the manufacture of a dietary supplement as required by 21 CFR 111.70(b)(1), as well as component specifications that are necessary to ensure that specifications for the purity, strength and composition of dietary supplements manufactured using the components are met, as required by 21 CFR 111.70(b)(2). Based on the discussion with firm management during the inspection, you have acknowledged that you have not established component specifications.
Once you have established appropriate specifications and before using a component that is a dietary ingredient, you must conduct at least one appropriate test or examination to verify the identity of the dietary ingredient, unless you petition the agency and the agency exempts you from such testing, as required by 21 CFR 111.75(a)(1)(i) and confirm the identity of other components consistent with 21 CFR 111.75(a)(2). You must also ensure that the tests and examinations that you use to determine whether the specifications are met are appropriate, scientifically valid methods, as required by 21 CFR 111.75(h)(1), and you must make and keep records, as required by 21 CFR 111.95.
3. Your firm failed to establish product specifications for the identity, purity, strength, and composition of the finished batch of each dietary supplement that you manufacture, as required by 21 CFR 111.70(e). Based on the discussion with firm management during the inspection, you have acknowledged that you have not established product specifications.
Once you establish product specifications, you must verify, for a subset of finished dietary supplement batches that you identify through a sound statistical sampling plan (or for every finished batch), that your finished batch of the dietary supplement meets product specifications for identity, purity, strength, and composition, as required by21 CFR 111.75(c).
4. Your firm failed to prepare and follow a written master manufacturing record (MMR) for each unique formulation of dietary supplement that you manufacture, and for each batch size, as required by 21 CFR 111.205.
5. Your written MMR failed to include all the elements required by 21 CFR 111.210. Specifically, your MMR failed to include complete information for the preparation of each unique formulation for each batch size of dietary supplement, such as the name of the product and the amount of each component by name and weight.
For example, the product label for your CV product lists Sarsaparrilla [sic] Root Extract, which is not included in your MMR as an added component to the finished product as required under 21 CFR 111.210(b). However, it is noted as an ingredient in your Technical and Safety Sheet for the product included in your BPR. Your MMR must ensure that the finished product meets specifications to ensure the quality of the product. Such specifications must ensure the composition of the finished product. We also suggest you review your labels to ensure that they accurately reflect the actual components used in product manufacturing.
6. Your batch production record (BPR) failed to include complete information relating to the production and control of each batch, as required by 21 CFR 111.255(b) and 111.260. For example, for your CV product, lots #334F06A04 and #334L204, you did not include:
- Documentation, at the time of performance, of the initials of the person performing the mixing of ingredients, the initials of the person responsible for verifying the weight/measure and addition of the component to the batch, and the packaging and labeling operations;
- The identity of the equipment used in the manufacture of the batch;
- The date and time of maintenance, cleaning and sanitizing of the equipment prior to their use in the production of the CV batches; and,
- A statement of the actual yield and a statement of the theoretical yield at critical production steps.
7. You firm failed to make and keep records that show that water, when used in a manner such that the water may become a component of the dietary supplement, meets the requirements of 111.15(e)(2), as required by 21 CFR 111.23(c). We note that foreign firms are required to meet all of their own national or local water safety requirements. Therefore, we suggest that your national or local safety requirements become part of your files.
8. Your quality control personnel failed to ensure that required representative samples are collected as required by 21 CFR 111.1 05(f). For example. the required representative samples were not obtained from each batch of finished products.
The violations cited in this letter are not intended to be an all-inclusive list of the 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. It is your responsibility to ensure that your facility and your products are in compliance with the Act and all applicable federal regulations.
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 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 Part 111) is Import Alert #54-14 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
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.
Please send your reply to Food and Drug Administration, Attention: Tyra S. Wisecup, Compliance Officer, 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.
Office of Compliance
Center for Food Safety
and Applied Nutrition