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U.S. Department of Health and Human Services

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Enforcement Actions

Organics Corporation of America DBA Ambix Laboratories 2/22/13

  

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

Public Health Service
Food and Drug Administration
 Central Region
Waterview Corporate Center
10 Waterview Blvd., 3rd Floor
Parsippany, NJ 07054
Telephone (973) 331-4911 

 

February 22, 2013
 

WARNING LETTER

VIA UPS OVERNIGHT

Mr. Alvin J. Goren, President
Organics Corporation of America (DBA Ambix Laboratories)
55 West End Road
Totowa, NJ 07512-1405
 

13-NWJ-05
 

Dear Mr. Goren:

The U.S. Food and Drug Administration (FDA) inspected your dietary supplement manufacturing facility located at 55 West End Road, Totowa, NJ from April 9, 2012 through May 7, 2012. During the inspection, our investigators found serious violations of the Current Good Manufacturing Practice (CGMP) regulation for dietary supplements, Title 21, Code of Federal Regulations, Part III (21 CFR Part 111). These violations cause your Baby Plex Vitamin Drops, Carnitine Liquid, and Optimal Nutritional Liquid 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 dietary supplements have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements.

Our inspection of your facility revealed the following violations of the dietary supplement CGMP regulation:

1. You failed to verify that your finished batch of dietary supplement meets product specifications for identity, purity, strength, composition, and for limits on those types of contamination that may adulterate or that may lead to adulteration of the finished batch of the dietary supplement, as required by 21 CFR 111.75(c). You may verify that these specifications are met by testing or examining 1) every finished batch or 2) a subset of finished batches for each of the dietary supplements you manufacture. If you test a subset of finished batches, you must identify the subset using a sound statistical plan, as required by 21 CFR 111.75(c).

Specifically, since 2010, your firm has manufactured and released approximately (b)(4) batches of Baby Plex Vitamin Drops, (b)(4) batches of Carnitine Liquid, and (b)(4) batches of Optimal Nutrition Liquid. However, you have not performed any testing to verify that any of the finished batches of dietary supplements meet product specifications for identity, purity, strength, composition, and for limits on those types of contamination that may adulterate or that may lead to adulteration of the finished batch of the dietary supplement, as required by 21 CFR 111.75(c).

We have reviewed your written response dated June 1, 2012 and have found that it does not adequately address this violation. Your response states that you updated finished product specifications "to include bulk product ID testing and conformational testing on all vitamins and minerals that appear on Supplement Facts panels for the next three (3) batches .... " You also state that you will then conduct rotational testing of vitamins and minerals for the next 9 batches and the 10th batch will be a conformational test. However, you have not provided a statistical basis for the rotational testing you appear to be using to identify a subset of finished dietary supplement batches through a sound statistical plan as set forth in 21 CFR 111.75(c). Further, your proposed corrective action does not verify that your finished batches of your dietary supplements meet product specifications, as required by 21 CFR 111.75(c). Your response does not address the specific violation that you failed to verify that your finished batch of dietary supplement meets product specifications for purity, strength, and for limits on those types of contamination that may adulterate or that may lead to adulteration of the finished batch of the dietary supplement.

2. You failed to conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient, as required by 21 CFR 111.75(a)(1)(i), and you failed to confirm the identity of other components that are not dietary ingredients and determine whether other applicable component specifications established in accordance with 21 CFR 111.70(b) were met, as required by 21 CFR 111.75(a)(2). Specifically:

• You did not determine whether the component specifications you established under 21 CFR 111.70(b) were met to ensure that specifications for the strength and composition of your Baby Plex Vitamin Drops (lot #20576) dietary supplement product were met for the following components: Niacinamide Granular (lot #32274-R); Niacinamide Granular (lot #31731-R); Thimine HCL (B1) (lot #31184-R); Pyridoxine HCL (B6) (lot #31439-R); DL-Choline Bitartrate (lot #32134-R); Vitamin B-12 USP (lot #32226-R); Riboflavin 5 Phosphate (B2) (lot #32008-R); and D Calcium Pantothenate USP (lot #31739-R). 

• You did not determine whether the component specifications you established under 21 CFR 111.70(b) were met for identity and to ensure that specifications for the strength and composition of your Optimal Nutrition Liquid (lot #20679) dietary supplement product were met for the following components: Actiphyte Skullcap (lot #23072-R); Pollen Extract 2:1 (lot #27505-R); Dimethylglycine Hydrochloride (lot #29834-R); Copper Sulfate USP (lot 30662-R); Folic Acid USP (lot #29151-R); Perforrnix E. Lecithin (lot#26088-R); Manganese Sulfate Monohyiirate (lot #29401-R); and Vitamin K1 USP (lot #28699-R).

• You did not determine whether the component specifications you established under 21 CFR 111.70(b) were met to ensure that specifications for the strength of your Carnitine Liquid (lot #20633) dietary supplement product were met for the following components: L-Carnitine (lot #32340-R); Glycerine (lots #32327-R, 32290-R, 32323-R); Methyl Paraben (lot #31914-R); and Propyl Paraben (lot #31 915-R). Additionally, you did not determine whether the specifications you established for Calcium Pantothenate (lot #31739-R) were met for identity and to ensure that specifications for the strength and composition of your Carnitine Liquid (lot #20633) dietary supplement product were met. 

We have reviewed your written response dated June 1, 2012, and have found that your response does not adequately address this violation. You state in your response that you are in the process of retesting all of your raw materials "as per current Ambix specification." However, your response did not provide the "current Ambix specification" for incoming raw materials. Furthermore, your response did not provide any supporting documentation for FDA to evaluate the adequacy of your proposed corrective action. You must conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient, as required by 21 CFR 111.75(a)(1). In addition, you may only rely on a certificate of analysis from the supplier of components that are not dietary ingredients if you first qualify the supplier by establishing the reliability of the supplier's certificate of analysis through confirmation of the results of the supplier's tests or examinations, as required by 21 CFR 111.75(a)(2)(ii)(A) and satisfy the other requirements specified in 21 CFR 111.75(a)(2)(ii).

3. You failed to make and keep documentation, in individual equipment logs, of the date of the use, maintenance, cleaning, and sanitizing of equipment, unless such documentation is kept with the batch record, as required by 21 CFR 111.35(b)(2). Specifically, your Work Instruction, Cleaning for Liquid Product Processing Vessels, Transfer Hoses and Transfer Pumps (WI-MF-05, Date Issued: 04/05/10), requires that cleaning performed on equipment be documented. However, your firm has not maintained records for cleaning and sanitizing equipment used to manufacture your dietary supplements. For example:
 

• On 02/15/2011, your firm utilized kettle (b)(4) to manufacture Baby Plex Vitamin Drops (lot #20461) and no records were maintained of the sanitization and cleaning of the vessel prior to use.

• On 07/29/2011, your firm utilized kettle (b)(4) to manufacture Carnitine Liquid (lot #20633) and no records were maintained of the sanitization and cleaning of the vessel prior to use.

• On 09/15/2011, your firm utilized kettle (b)(4) to manufacture Baby Plex Vitamin Drops (lot #20678) and no records were maintained of the sanitization and cleaning of the vessel prior to use.
 

We have reviewed your written response dated June 1, 2012, which states that your employees were retrained and that you have implemented a new process so that batches cannot be completed without proper documentation of equipment cleaning and sanitization. However, you did not provide sufficient supporting documentation for FDA to evaluate the adequacy of your proposed corrective action. We will verity the adequacy of your proposed corrective action at our next inspection. Additionally, your response included a memo stating that all manufactured batches must have a copy of the page from the Cleaning & Sanitization log book attached to manufacturing records for quality review. You must provide documentation of your new process in the Written procedures you must make and keep under 21 CFR 111.35(b)(1)(iii).

4. You failed to collect representative samples of each unique lot of components and packaging that you use to determine whether the components and packaging meet specifications established in accordance with 21 CFR 111.70(b) and (d), and as applicable, 21 CFR 111.70(a), as required by 21 CFR 111.80(a). Specifically:

Your procedure Sampling Procedure-Raw Materials (WI-QA-01, issue date: 10/14/2010) requires that (b)(4) sample per lot from any container be collected for analytical and microbiological testing. However, your firm is not collecting representative samples from each lot of components used in the manufacturing of your dietary supplements, such as your Baby Plex Vitamin Drops, Carnitine Liquid, and Optimal Nutrition Liquid dietary supplement products.

The above violations are not intended to be an all-inclusive list of violations at your facility or that exist in connection with your products or their labeling. 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 products are in compliance with the Act and FDA's implementing regulations. You should take prompt action to correct the violations cited in this letter and prevent their recurrence. Failure to promptly correct these violations may result in enforcement action without further notice, such as seizure and/or injunction.

In addition to the violations listed above, we have the following comment:

Under 21 CFR 111.455(a), you must hold components and dietary supplements under appropriate conditions of temperature, humidity, and light so that the identity, purity, strength, and composition of the components and dietary supplements are not affected. However, we note that your firm holds components such as Ascorbic Acid, Biotin, and Pyridoxine HCL, which are used to manufacture your Optimal Nutrition Liquid and Baby Plex Vitamin Drops dietary supplements, in a warehousing area in which the temperature is not controlled.

Your written response dated June 1, 2012 states that you have added temperature records and that you will monitor and document temperatures in your storage areas. This corrective action will be verified during the next inspection of your firm.

Within fifteen (15) working days from your receipt of this letter, please notify this office in writing of the specific steps you have taken to correct the violations noted above and to ensure that similar violations do not occur in the future. Your response should include any documentation necessary that would assist us in evaluating your corrections. lf you cannot complete all corrections within 15 working days, state the reason for the delay and the date by which you will correct any remaining violations.

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 there-inspection fees (21 U.S.C. 379j-31 (a)(2)(B)). 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 noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection-related costs.

Your written response should be sent to the attention of Compliance Officer, Stephanie Durso, at the U.S. Food and Drug Administration, 10 Waterview Blvd, 3rd Floor, Parsippany, NJ 07054. If you have questions regarding any issues in this letter, please contact Stephanie Durso at 973-331-4911.
 

Sincerely,

/S/

Diana Amador-Toro
District Director
New Jersey District