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CLOSEOUT LETTER

VitaCare Pharma, LLC MARCS-CMS 485167 —


Recipient:
Recipient Name
Dr. Manav Shah
VitaCare Pharma, LLC

111 Skyline Drive

South Plainfiled, NJ 07080
United States

Issuing Office:
New Jersey District Office

United States


  

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

Public Health Service
Food and Drug Administration
 
New Jersey District Office
Central Region
Waterview Corporate Center  
10 Waterview Blvd. 3rd Floor
Parsippany, New Jersey 07054
Telephone: (973) 331- 4900
FAX: (973) 331- 4969

 

March 7, 2016
 
 WARNING LETTER
 
 
VIA UNITED PARCEL SERVICE
Overnight Delivery
Return Receipt Requested
 
Dr. Manav Shah, President and Owner
VitaCare Pharma, LLC
111 Skyline Drive
South Plainfield, NJ 07080                                                                 16-NWJ-04
 
Dear Dr. Shah:
 
The U.S. Food and Drug Administration (FDA) conducted an inspection of your dietary supplement facility, located at 111 Skyline Drive, South Plainfield, New Jersey, from October 13, 2015 through November 3, 2015. Based on our inspection, we found serious violations of the Current Good Manufacturing Practice (CGMP) regulation for Manufacturing, Packaging, Labeling, or Holding Operations 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 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 regulations for dietary supplements found under 21 CFR Part 111. You can find the Act and its implementing regulations through links on FDA’s home page at http://www.fda.gov
 
We received your written response, dated November 23, 2015, to the Form FDA 483. Your response is discussed in more detail below.
 
Our inspection revealed the following violations:
 
1.    Your quality control operations failed to determine whether all components, packaging, and labels conform to specifications established under 21 CFR 111.70(b) and (d) before use in the manufacture of dietary supplements, as required by 21 CFR 111.120(b). Specifically,
 
A.    Synephrine HCL (b)(4) was not tested for strength of (b)(4) before being used to manufacture HerDiet Pink Capsules (Batch # 15I003) and PhenRx Capsules (Batch # 15A002).
 
B.    Schizandrol A (b)(4) was not tested for strength or purity before being used to manufacture HerDiet Pink Capsules (Batch # 15I003) and PhenRx Capsules (Batch # 15A002).
 
We received your response, dated November 23, 2015, to the Form FDA 483, Inspectional Observations issued at the close of the inspection. We find your response to be inadequate in that you provided testing results of Synephrine HC1; however, you did not include testing results for strength of (b)(4). You also stated that you sent out Schizandrol (b)(4) for testing; however, you are awaiting the results.
 
2.    You failed to establish the reliability of the supplier's certificate of analysis through confirmation of the results of the supplier's test or examinations, as required by 21 CFR 111.75(a)(2)(ii)(A), and to maintain documentation of how you qualified the supplier, as required by 21 CFR 111.75(a)(2)(ii)(C). You relied on certificates of analysis (COA) from the suppliers of components used in your dietary supplement products to confirm the identity of these components, but failed to qualify the suppliers of components used in your dietary supplement products by establishing the reliability of the supplier's COA through confirmation of the results of their tests or examinations. Specifically,
 
A.    You failed to establish the reliability of the supplier’s certificate of analysis through confirmation of the results of the supplier’s tests or examinations, and you failed to maintain documentation of how you qualified and confirmed your supplier’s certificate of analysis for Xanthoparmelia Scabrosa (b)(4) and accepted the component for release based on their results for strength.
 
B.    You failed to establish the reliability of the supplier’s certificate of analysis through confirmation of the results of the supplier’s tests or examinations, and you failed to maintain documentation of how you qualified and confirmed your supplier’s certificate of analysis for Dong Quai (b)(4) and accepted the component for release based on their results for microbial analysis and heavy metal analysis. This component was used to manufacture Mammorex Breast Capsules (Batch # 15I021) on September 17, 2015.
 
We received your response, dated November 23, 2015, to the Form FDA 483, Inspectional Observations issued at the close of the inspection. We find your response to be inadequate in that you only sent your suppliers a Vendor Qualification Audit Questionnaire rather than establishing the reliability of the supplier’s certificate of analysis through confirmation of the results of the supplier’s tests or examinations.
 
3.    Your quality control personnel failed to conduct a material review and make a disposition decision when a specification established in accordance with 21 CFR 111.70 is not met, as required by 21 CFR 111.113(a)(1). Specifically, your Udamin SP Tablets Batch # 14K009 did not meet their specification for hardness. Multiple tablets taken throughout the tableting process tested below the minimum hardness specification of (b)(4). However, no investigation was initiated to determine the reason for the out of specification results and this lot was released by quality control on 02/03/2015 and distributed on 02/18/2015.
 
We received your response, dated November 23, 2015, to the Form FDA 483, Inspectional Observations issued at the close of the inspection. We find your response to be inadequate in that you provided no evidence or documentation that indicates how your quality control proposes to handle products that do not meet specifications.
 
4.    Your batch production record failed to include the identity and weight or measure of each component used as required by 21 CFR 111.260(e). Specifically,
 
A.    On October 22, 2015, FDA investigators observed technicians weighing a component of Rice Flour (b)(4) in its original (b)(4) without documenting the actual weight on the batch record for US Vitamin D3 5000 V capsules, Batch # 15J024.
 
We received your response, dated November 23, 2015, to the Form FDA 483, Inspectional Observations issued at the close of the inspection. We are unable to evaluate the adequacy of your response because you provided revised BPR’s for Dandelion Root 520 mg Capsules (VC CODE # VC4277/BACTH # 15K024 and Gluco + Chon +MSM Capsules (VC CODE # VC4284/ BACTH # 15K012). However, these BPR’s are not specific to the L-Lysine product that was observed during the inspection. We intend to verify the adequacy of this corrective action at a future inspection.
 
5.    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, no documentation was provided during the inspection to show that the laboratory methodology established for Chloride and Heavy Metal Testing, at the time of performance, was followed. For example:
 
A.    Chloride and Heavy Metal testing was performed for L-Arginine base (b)(4) with no documentation to show that the laboratory methodologies established were followed at the time of performance. This component was used in the manufacture of L-Arginine 500 mg Capsules for Batch # 15F040 on June 25, 2015.
 
We received your response, dated November 23, 2015, to the Form FDA 483, Inspectional Observations issued at the close of the inspection. We are unable to evaluate the adequacy of your response because you provided blank forms with no documentation of implementation of your corrective actions.
 
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 violation. It is your responsibility to ensure that all of your firm’s products are in compliance with the Act and applicable FDA regulations. You should take prompt action to correct the violation cited in this letter. Failure to promptly correct the violation may result in legal action without further notice including seizure or injunction. 
 
Comment:
  • Your firm includes expiration dates on the labels for your dietary supplement products. For example, the labels on your dietary supplements: Monster Xplosion capsules and HerDiet Pink capsules have a 3 year shelf life. Similarly, the label on your dietary supplement Stimuloid US Capsules has a 2 year shelf life.
Any expiration date and storage conditions you place on a product label should be supported by data that demonstrates the product’s shelf life under the recommended storage conditions [See 72 Fed. Reg. 34752, 34856 (Jun. 25, 2007)]. Please note that the term “expiration date” includes shelf life dating as well as ‘‘best if used by’’ dating [See 72 Fed. Reg. 34912, 34856 (Jun. 25, 2007)].
 
We note that your written response provided a blank template that you provide to your clients that ask them to verify the shelf life dating; however, no supportive documents were provided to explain the justification for the expiration date.
 
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 each violation including an explanation of each step taken to prevent the recurrence of violations and copies of supporting documentation. If you cannot complete corrective actions within fifteen working days, state the reason for the delay and the date by which you will have completed the correction.
 
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 non-compliance 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 noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection-related costs.
 
Your response should be sent to the following address: U.S. Food and Drug Administration, 10 Waterview Blvd., Parsippany, 3rd Floor, New Jersey 07054. If you should have any questions regarding any issue in this letter, please contact Robert J. Maffei, Compliance Officer, at 973-331-4906.
 
Sincerely,
/S/ 
Craig W. Swanson
Acting District Director
New Jersey District

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