- VitalHealth Tech Inc.
- Issuing Office:
- New Jersey District Office
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Telephone (973) 331-4904
October 30, 2014
VIA- OVERNIGHT DELIVERY
Mr. Mukesh D. Solanki
President and Owner
VitalHealth Tech, Inc.
1 Carol Street
Clifton, New Jersey 07014
Dear Mr. Solanki:
On May 29, 2014 through June 18, 2014, an investigator with the U.S. Food and Drug Administration (FDA) inspected your facility located at 1 Carol Street, Clifton, New Jersey. During the inspection, our investigator found a number of serious violations of the Current Good Manufacturing Practice (CGMP) regulations for Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR 111). These violations cause dietary supplement products manufactured by your firm, including "Kids Mighty Vites," "Omni Jr." wafers, and "Weight Loss 4" 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 they have been prepared, packed, or held under conditions that do not meet the CGMP requirements for dietary supplements. These CGMP violations were listed on the Inspectional Observations (FDA-483) form issued to you at the close of the inspection on June 18, 2014. We acknowledge receipt of your letters, dated July 3, 2014 and August 15, 2014, and address them below. You may find the Act and FDA's regulations through links on FDA's home page at www.fda.gov.
The inspection revealed the following serious CGMP deficiencies:
1. You failed to establish 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 CPR 111.70(b)(2). Specifically, during the inspection you stated that you do not have established specifications for the dietary ingredient components used to manufacture your dietary supplements. For example, you do not have component specifications for the dietary ingredients in the following products:
• Kids Mighty Vites tablets, which include Vitamin A, Vitamin B6, Folic Acid, Selenium, and Choline (lots #201102029, #201109041, #201203001, #201211002, and #201308042);
• Omni Jr. Wafers, which include Vitamin B12, Vitamin D3, Vitamin E, Zinc, and Hespiridin (lots #201110018, #201206002, and #201307028);
• Weight Loss 4 tablets, which include Garcinia Cambogia extract, Green Coffee Extract, Raspberry Ketone, and White Mulberry Leaf Extract (lots #201401005, #201401006,#201401007,#201401008,#201401009,#20140512,#201405013, and #201405014).
Once you have established specifications for dietary ingredient components, you must verify that the specifications are met in accordance with 21 CFR 111.73, and you must make and keep records of such specifications in accordance with 21 CFR 111.95(b)(1).
We acknowledge in your response dated July 3, 2014, that you stated that you have established specifications for five raw component materials and will continue to generate additional dietary ingredient specifications. Your response is inadequate because you only provided an established specification for one dietary ingredient Garcinia Cambogia Extract 50% and not all components, or even the five raw component materials as you stated in your response. In addition, the established specification you provided was not approved by quality control, as required in 21 CFR 111.105(a). Additionally, your August 15, 2014 response is also inadequate because you failed to provide supporting documents that you have established specifications for the (b)(4) raw materials that you state you have created specifications for.
2. 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). Specifically, you have established specifications for the identity, purity, strength, and composition of your finished dietary supplement products, Kids Mighty Vites and Omni Jr. Wafers; however, your means of verifying whether specifications for the strength and composition of four of the dietary ingredients: soy lecithin, citrus bioflavonoid, hesperidin, and pectin are met is inadequate. Your means of verifying strength and composition of these dietary ingredients are "Based on Input" or "Ensured by documented control," meaning that your operators have identified that they have added the ingredients to the batch of product. Ensuring that an ingredient is added to the batch of product does not provide adequate assurance that the finished product specifications are met. You told our investigator that you were unable to assay these ingredients in-house or through your contract laboratory, so the quantities listed on your certificate of analysis were based on input.
We acknowledge in your response dated July 3, 2014, that you indicated that you retrained your employees to follow your SOPs and that the next three consecutive lots of Kids Mighty Vites and Omni Jr. Wafer will be tested for all ingredients. However, your response is inadequate because you did not provide the testing method for the four ingredients.
3. You failed to hold components under appropriate conditions of temperature, humidity, or light so that their identity, purity, strength, and composition are not affected, as required by 21 CFR 111.455(a). Specifically, your firm does not monitor the temperature and humidity of the warehouse and pharmacy areas used to hold raw materials. Dietary ingredients are not being stored under appropriate environmental conditions in order to ensure that their purity, strength, and composition are not compromised. For example, our investigator observed Dry Vitamin A Acetate 500 stored in the warehouse area without temperature and humidity monitoring. The product label stated to store the ingredient at below 59F. Also, a container: of Lactobacillus Acidophil us, which needs to be stored under refrigeration, was observed being stored at ambient temperature.
We acknowledge in your response dated July 3, 2014, that you indicated that you have destroyed the affected lot of Lactobacillus Acidophil us material and placed the Dry Vitamin A in a temperature controlled room. You also stated that your quality department will evaluate the results of the testing of the affected lot of Dry Vitamin A for disposition. You further stated that you will conduct a temperature and humidity mapping study of your warehouse and pharmacy areas, establish an SOP for monitoring temperature and humidity, and perform inventory review for each ingredient. Your response is inadequate because you did not address what your plan is for all the ingredients that require temperature and humidity control while you are waiting for the mapping study and the development of the monitoring SOP. In addition, you only conducted identity testing on the Dry Vitamin A Acetate 500. Data to support meeting the requirements of purity, strength, and composition were not provided to ensure that the material has not been impacted by the storage conditions.
4. Your quality control personnel failed to reject, treat, or reprocess a dietary supplement when a specification was not met as required under 21 CFR 111.113(b)(2). Specifically, your Omni Jr, Wafers, Lot #201110018 was tested by your firm's contract laboratory, (b)(4), and shown to have a presumptive positive for Escherichia coli. Your established Omni Jr. Wafers finished product specification for E. coli is "(b)(4)." You did not conduct a confirmation test on the presumptive positive sample. Instead, your firm sent a second sample of the same lot to a different contract testing laboratory, (b)(4) and received a negative result for E. coli.
We acknowledge in your response dated July 3, 2014, you indicated that you contacted your customer that received the subject lot of finished product and verified that all products have been exhausted and that you have revised your SOP for Test Plan for Finished Products to include the requirement that all confirmation microbial testing be performed on the same sample submitted to the contract laboratory. Your response is not adequate because you did not further investigate whether there are other batches of finished product that were released based on presumptive positive results, nor did you contact the contract laboratory to determine if they were able to conduct a confirmatory test on that presumptive positive result.
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products. It is your responsibility to ensure that all of your products are in compliance with the Act and its implementing regulations. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and/or injunction.
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 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 reinspectionrelated costs.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations, including an explanation of each step taken to prevent the recurrence of violations and copies of supporting documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the date by which you will have completed the correction.
Your response should be sent to the following address: U.S. Food and Drug Administration, 10 Waterview Boulevard, 3rd Floor, Parsippany, New Jersey 07054. If you should have any questions regarding any issue in this letter, please contact Andrew Ciaccia, Compliance Officer at 973-331-4904.
New Jersey District