- Delivery Method:
- UPS Overnight
Mr. K. Gnaneshwar Rao
- Unique EnCapsulation Technology LLC
9 Lenel Road
Landing, NJ 07850
- Issuing Office:
- New Jersey District Office
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New Jersey District
Waterview Corporate Center
10 Waterview Blvd. 3rd Floor
Parsippany, NJ 07054
Telephone: (973) 331-4900
FAX: (973) 331-4969
January 17, 2017
VIA UPS OVERNIGHT
Mr. K. Gnaneshwar Rao, CEO and Founder
Unique EnCapsulation Technology LLC
9 Lenel Road
Landing, NJ 07850 17-NWJ-03
Dear Mr. Rao:
The U.S. Food and Drug Administration (FDA) inspected your dietary supplement manufacturing facility located at 9 Lenel Road, Landing, NJ from May 23, 2016 through June 21, 2016. Serious violations of the Current Good Manufacturing Practice (CGMP) regulation for dietary supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111) were documented during this inspection. These violations cause your (b)(4), and (b)(4) 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.
We received your written responses, dated June 30, 2016 and September 19, 2016, concerning our Investigators’ observations noted on the Form FDA 483 (FDA 483), List of lnspectional Observations, that was issued to your firm on June 21, 2016. We address your responses below, in relation to each of the noted violations. Our inspection of your facility revealed the following violations of the dietary supplement CGMP regulation, including but not limited to:
1. You failed to establish specifications for the identity of components as required by 21 CFR 111.70(b)(1). You also failed to establish component specifications necessary to ensure that specifications for the purity, strength, and composition of dietary supplement manufactured using the components are met, as required by 21 CFR 111.70(b)(2). For example, you failed to establish specifications for the components Vitamin K2 (MK-4), Vitamin K2 (MK-7), Vitamin D3 MCT Oil, Marigold, BetaCarotene, Astaxanthin, Black Currant, Hemp Oil, Life’s DHA, AstaReal L10, and Turmeric Blend. Once you have established the specifications for each component, you must verify that the specifications are met in accordance with 21 CFR 111.75(a), and you must make and keep records in accordance with 21 CFR 111.95(b).
We have reviewed your written responses, dated June 30, 2016 and September 19, 2016 and have determined that your responses did not provide sufficient information to determine if the component meets its specifications (i.e., the specifications are not appropriate in that they failed to uniquely identify the necessary acceptance criteria for each the required specifications).
2. You failed to establish product specifications for the purity and strength of the finished batch of the dietary supplement to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(e). Specifically, your finished product specifications for the (b)(4) product do not include a specification for the product’s label declaration of containing 95% of Curuminoids nor do they include a specification for the presence of essential oils of Turmeric Rhizome.
We have reviewed your written responses, dated June 30, 2016 and September 19, 2016. Your responses cannot be evaluated because of a lack of supporting documentation. Your responses states you are working with a third party laboratory to provide testing that will ensure the product will meet the finished label claim but did not provide evidence of the controls which will be in place during the interim timeframe.
3. When a dietary supplement failed to meet an established specification, your quality control personnel did not reject the component or dietary supplement, nor did they approve a treatment, an in-process adjustment, or reprocessing that would ensure the quality of the finished dietary supplement and that the dietary supplement was packaged and labeled as specified in your master manufacturing record (MMR), as required by 21 CFR 111.77(a) and 111.113(b)(2); nor did your firm’s quality control personnel conduct a material review and make a disposition decision when the established specification was not met, as required by 21 CFR 111.113(a)(1).
Specifically, out of specification results were received for component Vitamin K2 (MK-4), Lot 001307A and finished product, (b)(4), Lot 14111901, tested by your laboratory personnel. Instead of rejecting the component, you continued to re-test the component and finished product for the microbial specification until the test results indicated that the established specification was met. Your quality control unit failed to reject Vitamin K2 (MK-4), Lot 001307A, which was released and used in the manufacturing of a finished product or reject the finished product, (b)(4), which was released for distribution.
We have reviewed your written responses, dated June 30, 2016 and September 19, 2016, and the adequacy of the responses cannot be determined at this time. These responses included an attachment of a (b)(4) study performed in 2011 but you referenced a (b)(4) and did not explain how it related to these results. In addition, your June 30, 2016 response stated that the related corrective actions regarding re-testing of the (b)(4) product and re-calibration of equipment were expected to be completed on August 15, 2016 but your September 19, 2016 response did not provide any further evidence of or reference these corrective actions.
4. You failed to ensure that the test 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). Specifically, you stated in your September 19, 2016 response that you will develop (b)(4) This is not considered a valid scientific method. In order to use the method of verifying dietary ingredients by (b)(4) you must use acceptable reference standards. Using (b)(4) is not an acceptable reference standard.A valid scientific method is required to be used or developed from which components are tested against acceptable reference standards.
5. Your batch production records failed to include an actual or representative label, or a cross- reference to the physical location of the actual or representative label specified in the master manufacturing record, as required by 21 CFR 111.260(k)(2). Specifically, the batch records for the (b)(4), lot number 15081101, did not contain representative product labeling or a cross reference to a representative product labeling.
6. You failed to make and keep records that laboratory methodology established in accordance with subpart J is followed, and the person who conducts the testing and examination is documenting at the time of performance that laboratory methodology established in accordance with subpart J is followed, as required by 21 CFR 111.325(b)(2)(i). Specifically, your quality control unit’s chemist did not accurately document use of the High Performance Liquid Chromatography (HPLC) equipment from February 24, 2016 through April 18, 2016. The results obtained from use of this equipment were used to release and distribute products. For example:
a. The sample and standard weights used in the calculation of the weight of active ingredient, curcuma longa root extract, within (b)(4), Lot 16033001; the HPLC Analysis results document states the weight of sample used as (b)(4) and the weight of the standard used as (b)(4); however, the calculation provided to obtain the testing result stated the weight of sample as (b)(4) and the weight of standard as (b)(4). You were not able to provide the actual weights used during this analysis(4to)our Investigators.
b. There is no documentation of the use of a HPLC instrument for testing of (b)(4)
, Lot 16033001, (b)(4)
150 mg, Lot 16011102; and (b)(4)
, Lot 16021701.
We have reviewed your written responses, dated June 30, 2016 and September 19, 2016, and conclude that the adequacy of the responses cannot be determined at this time. You state in your June 30, 2016 response that procedures and work instructions will be updated, log books will be assigned to personnel with preprinted labels with the required information to be documented, the Laboratory Manager will conduct daily reviews of the notebooks, Quality Control will perform weekly reviews of the notebooks, and training will be provided. However, this response and your September 19, 2016 response did not provide evidence of these corrective actions for review .
7. You failed to follow written procedures for laboratory operations, including written procedures for the tests and examinations that you conduct to determine whether specifications are met, as required by 21 CFR 111.303.
Specifically, your test method (b)(4), was not followed for weight used in sample preparation of the active ingredient for (b)(4), Lot #16011101. On January 21, 2016, the test method states (b)(4) of sample is to be used, however, the analyst used (b)(4) of sample for testing.
We have reviewed your written responses, dated June 30, 2016 and September 19, 2016, and conclude that the adequacy of the response cannot be determined at this time. Your June 30, 2016 response states a deviation report will be written and training will be performed, however, you did not include any explanation for this observation and you did not provide sufficient supporting documentation. This response also stated that procedures and test procedures will be updated to reflect exactly the process and procedures utilized to conduct testing for the release of materials, lab log book assignment, review and approval processes with an expected completion date of September 30, 2016. Your September 19, 2016 response did not further address this observation or any additional information regarding implementation of updated laboratory processes.
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. 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.
We offer the following comments:
1. Your firm includes expiration dates on the labels for the dietary supplement products you contract manufacture, including (b)(4), lot number 15081101, (b)(4) 600 mg, lot number 16033001, and (b)(4) 150 mg, lot number 16010401. During the inspection, you informed our Investigators that you did not conduct or have any data supporting the expiration dates listed on the product labels. Any expiration date you place on a product label should be supported by data that demonstrates the product’s shelf life [See 72 Fed. Reg.
34752, 34856 (Jun. 25, 2007)].
2. You failed to provide water that is safe and sanitary for all uses where water does not become a component of a dietary supplement in accordance with 21 CFR 111.15(e)(1). Water testing conducted May 29, 2015 through June 5, 2015 and June 15, 2015 through June 22, 2015 demonstrated failing results for yeast and mold but you did not perform any corrective actions. You informed our Investigators the water subject to this testing is used for cleaning the equipment used to manufacture dietary supplement products.
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. If 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 the re-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 Branch, at the U.S. Food and Drug Administration, 10 Waterview Blvd, 3rdFloor, Parsippany, NJ 07054. If you have questions regarding any issues in this letter, please contact Acting Compliance Officer, Barbara Wilimczyk-Macri, at 732-390-3828.
Craig W. Swanson
Acting District Director
New Jersey District