El-Gen LLC 8/3/12
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New York District
158-15 Liberty Avenue
Jamaica, NY 11433
WARNING LETTER NYK-2012-22
AUG 3, 2012
Mr. Roy McKeen, President
138 Haven Ave Ste 101
Port Washington, NY 11050
Dear Mr. McKeen:
The United States Food and Drug Administration (FDA) inspected your firm, a dietary supplement manufacturer, located at 7 Shirley St, Bohemia, New York, on January 26 through 31, 2012. Our investigation revealed significant violations of the Current Good Manufacturing Practice (CGMP) regulation for dietary supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). These violations cause your dietary supplement products to be adulterated under Section 402(g)(1) of the Federal Food, Drug and Cosmetic Act (the Act), 21 U.S.C. § 343(g)(1), because they have been prepared, packed or held under conditions that do not meet the CGMP regulations for dietary supplements.
In addition, we have reviewed the labels for your Rejeneril A (4 oz., 8 oz.), Cellvox Cell Energy, and Cell Power products. Based on our review, we have concluded that these products are misbranded under Section 403 of the Act, 21 U.S.C. § 343, in that their labels do not comply with FDA’s regulations under 21 CFR Part 101.
You may find the Act and the CFR through links in FDA’s home page at www.fda.gov
Your significant violations are as follows:
Dietary Supplement CGMP Violations:
1. Your firm failed to conduct at least one appropriate test or examination to verify the identity of a component that is a dietary ingredient, prior to its use, as required by 21 CFR 111.75(a)(1)(i). Specifically, the dietary supplement Rejeneril, lot #110911, contains the dietary ingredient, Vitamin A Acetate, lot #2AI0072, for which no identity testing was conducted prior to its use. The lot of Rejeneril was subsequently released by your firm’s quality control personnel.
We have reviewed your response, dated February 13, 2012 and have noted that samples of your current inventory of this ingredient were forwarded to (b)(4) on February 9, 2012 for Vitamin A Acetate identification analysis, and that you anticipated the results within 10 days. We have not received these test results.
2. Your firm failed to establish product specifications for each dietary supplement you manufacture (21 CFR 111.70(e)). Specifically, you have not established product specifications for your Rejeneril A product, other than specifying the amount of Vitamin A in the master manufacturing record. You are also required to determine whether these specifications are met (21 CFR 111.73) by testing the finished batch of dietary supplement in accordance with testing requirements in 21 CFR 111.75(c).
We have reviewed your response, dated on February 13, 2012 and have noted that you have developed a new HPLC method for identifying Vitamin A Acetate in this product. You also stated that you were developing a method for quantifying Vitamin A Acetate in your products, but you did not furnish either method for our review. You also stated that (b)(4) had the capability to conduct identity/qualification tests for Vitamin A Acetate in your dietary supplements, and that you contracted their services. However you have not provided us with product specifications and the results to show Rejeneril A met these specifications.
3. You did not make and keep written procedures for the responsibilities of the quality control operations to include written procedures for conducting a material review and making a disposition decision and written procedures for approving or rejecting any reprocessing, as required by 21 CFR 111.140(b)(1). You also did not make and keep records of written documentation, at the time of performance, that quality control personnel performed the review, approval, or rejection requirements, as required by 21 CFR 111.140(b)(2). Moreover, you did not document any material review and disposition decision and follow-up, as required by 21 CFR 111.140(b)(3). In addition, you failed to identify who is responsible for your quality control operations, as required by 21 CFR 111.12(b). Each person who is identified must be qualified to perform quality control operations and have distinct and separate responsibilities related to performing such operations from those responsibilities that the person otherwise has when not performing such operations [21 CFR 111.12(b)]. Specifically, at the time of the inspection you had not identified employees specifically responsible for your quality control operations; there was no quality control oversight of materials receipt, documentation of packaging activities, review of packaging records and disposition decisions, review and disposition of returned dietary supplements, and review of complaint information to determine if additional investigation and/or follow-up was warranted.
We have reviewed your response, dated February 13, 2012, and have determined your response to be inadequate. In your response to Observation 5, you state that you have developed a Standard Operating Procedure labeled SOP 2v.1 "Quality Assurance Program" qualified personnel, that was made effective February 13, 2012, and which you attached as "Exhibit VII". Further, we reviewed your attached SOP ID#23v.2. However, these SOPs do not meet the requirements of 21 CFR 111.140(b)(l), 21 CFR 111.140(b)(2) and 21 CFR 111.140(b)(3). Your SOPs reference other SOPs, but these other SOPs were not provided to us for evaluation to determine their adequacy and your SOPs do not describe specific procedures. For example, there is no specific written procedure directing a designated quality control personnel to perform an identity test or an assay of the dietary ingredient in the dietary supplement in question to determine whether the established specifications were met.
Misbranded Dietary Supplements
1. Your Rejeneril A (4 oz., 8 oz.), Cellvox Cell Energy, and Cell Power Dietary Supplement products are misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. 343(q)(5)(F)] in that the nutrition information on their product labels do not comply with 21 CFR 101.36.
Examples of the deviations from the requirements of 21 CFR 101.36 include:
- The labels for your products do not identify the Percent Daily Value for Molybdenum, as required by 21 CFR 101.36(b)(2)(iii).
- The labels of your products do not correctly lists the order of the dietary ingredients. Specifically, your riboflavin, Vitamin B12 (cyanocobalamin), and sodium are not in the correct order, as required by 21 CFR 101.36(b)(2)(i)(B).
- The labels of your products do not list the correct nomenclature for two of the dietary ingredients, as required by 21 CFR 101.36(b)(2)(B). Specifically, thiamine hydrochloride and cyanocobalamin are not listed according to the nomenclature specified in 21 CFR 101.9 or 101.36(b)(2)(i)(B)(2). For example, your ingredient “Thiamine hydrochloride” should be listed as either thiamin, thiamin (vitamin B1) or thiamin (as thiamin hydrochloride). Similarly, “Cyanocobalamin” should be listed as vitamin B12 or vitamin B12 (as cyanocobalamin) as illustrated in 21 CFR 101.36(e)(11)(i).
- The labels list both dietary ingredients with an established Reference Daily Intake (RDI) (e.g., Vitamin A, thiamine, riboflavin) and dietary ingredients for which FDA has not set a Daily Reference Value (DRV) or RDI (e.g., alpha lipoic acid, palladium, n-acetyl cysteine) as defined under 21 CFR 101.36(b)(2) and (b)(3), respectively. However, these labels do not segregate the 21 CFR 101.36(b)(2) and (b)(3) dietary ingredients into separate sections of the supplement facts panel as required by 21 CFR 101.36(b)(3)(i).
- Additionally, heavy bars are required immediately after the listing of the last dietary ingredient required to be declared pursuant to 21 CFR 101.36(b)(2) and (b)(3), respectively (21 CFR 101.36(e)(6)(ii) and (iii)).
- The labels for your products lack a heavy bar beneath the subheading “Serving Per Container, as required by 21 CFR 101.36(e)(6)(i).
2. Your products are also misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C § 343(i)(2)] because they contain ingredients that are not declared on the label, as required by 21 CFR 101.4. Specifically, according to your master manufacturing record, these products contain purified water, but this is not listed on the labels.
Also, the labels for your products list "Other ingredients" inside the Supplement Facts box. Under 21 CFR 101.4(g), the ingredient list on dietary supplement products must be located outside the Supplement Facts box. A source ingredient that supplies a dietary ingredient may be identified within the Supplement Facts box in accordance with 101.36(d). When a source ingredient is listed in the Supplement Facts box, you must list the remaining ingredients outside the Supplement Facts box preceded by the words "Other Ingredients" to comply with 21 CFR 101.4(g).
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 re-inspection-related costs. A re-inspection 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. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees (21 U.S.C. 379j-31(a)(2)(B)). FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic 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 re-inspection-related costs.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. 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 reply to the Food and Drug Administration, Attention: Kristen C. Jackson. If you have questions regarding any issues in this letter, please contact Kristen Jackson at 718-662-5711.
New York District