• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

  • Print
  • Share
  • E-mail

N.V.E. Pharmaceuticals, Inc. 7/22/13

  

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 

July 22, 2013
 

Warning Letter

Via UPS Overnight

Robert Occhifinto
President/Owner
N.V.E. Pharmaceuticals, Inc.
15 Whitehall Road
Andover, New Jersey 07821
 

File No.: 13-NWJ-11
 

Dear Mr. Occhifinto,

From September 11 through September 26, 2012, the U.S. Food and Drug Administration (FDA) conducted an inspection of your dietary supplement manufacturing facility, N.V.E. Pharmaceuticals, Inc., 15 Whitehall Road, Andover, NJ. The inspection revealed serious violations of the Current Good Manufacturing Practice (CGMP) regulation for Dietary Supplements, Title 21, Code of Federal Regulations (CFR), 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. We have received your written responses dated October 11, 2012 and January 15, 2013 and found your responses to be inadequate for the reasons outlined below.

In addition, we have reviewed certain product labels. Based on our review, we have determined that these products are misbranded under Section 403 of the Act (21 U.S.C. § 342) for the reasons explained below.

You may find the Act and FDA regulations through links at FDA's home page at http://www.fda.gov.

CGMP Violations:

1. You failed to establish required specifications for points, steps, or stages in your manufacturing processes where control is necessary to ensure the quality of the dietary supplement, as required by 21 CFR 111.70. Specifically:

a) You failed to establish component specifications, as required by 21 CFR 111.70(b). Our investigators found that you have not established specifications for the dietary ingredients used in your dietary supplements.

b) You failed to establish product specifications for the identity, purity, strength, and composition of the dietary supplements you manufacture, as required by 21 CFR 111.70(e). Specifically, during our inspection we reviewed your manufacturing records and based on our review you have not established product specifications for the dietary supplements you manufacture.

In addition, please note that manufacturers are responsible for more than establishing specifications. Once you have established the specifications under 21 CFR 111.70, you must determine whether the specifications have been met [21 CFR 111.73].

We have reviewed your October 11, 2012 and January 15, 2013 responses and do not consider them to be adequate. In order for your firm to be compliant you must establish specifications that are an explicit set of requirements, a standard value set for the material (a dietary ingredient, component, or dietary supplement) used or manufactured and to be satisfied and met in order for your firm to be considered in conformance with its specifications. The specifications should describe the technical characteristics of the (dietary ingredient, component or dietary supplement) type of analyticalmethod to be use(d) to determine whether to accept or reject the ingredient, or component or product being analyzed. You provided examples of specifications for dietary ingredients and finished product batches, however, these examples did not meet these requirements. We note what appears to be an error in your response. The last sentence of your response on page 2 included under observation 5 stated "After which a marker ingredient will be chosen for each product and will"; however this is an incomplete statement of your intended actions.

Furthermore, you claim that you will establish quantitative and qualitative parameters with limits for your finished batches and finished goods however, the submitted finished liquid product specification sheet for the (b)(4), and the Stacker 2 Gyrating Grape Carbonated products use organoleptic analysis methods along with non-defined compendial methods and/or by input to determine how the established specifications will be met. Each of the specification reports are inadequate in that they did not reference a specific method to determine how the established specifications are to be met.

2. You 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, you manufactured dietary supplements without verifying the identity of the dietary ingredients used in your products. Those dietary supplements include Stacker 2 brand, "7-Phenyl Stack Diet and Energy" capsules; "6 Hour Power Energy Shot"; "Stacker 2" capsules; "Extreme Energy Kickin Classic Zero"; "SLEEP EASE" Shot; and "Vitamin D3 Shot."

We have reviewed your October 11, 2012 and January 15, 2013 responses and do not consider them to be adequate. You provided three(3) NVE Pharmaceuticals specifications documents for the Caffeine Anhydrous, 6 Hour Power and the Stacker 2 Gyrating Grape Carbonated products, however, these documents do not reference a specific method to be used to determine how the established specification is met.

3. You failed to take necessary precautions during the manufacture of a dietary supplement to prevent contamination of dietary supplements, as required by 21 CFR 111.365. Specifically, our investigators observed the following:
 

• horizontal pipes located above a top loading (b)(4) gallon mixer were covered with an unknown crystallized residue and condensate dripping into the mixer
 

• the walls, electrical outlet covers, ceiling tiles, and air ducts of the room containing a (b)(4) blender were covered with dust
 

• an employee's gloved hand touching product contact surfaces after touching a metal ladder.
 

Furthermore, you failed to use sanitary handling procedures during filling, packaging, and labeling operations, as required by 21 CFR 111.415(c).
Specifically, our investigators observed:
 

• empty and filled open bottles on the filling lines are not protected from foreign materials from entering the bottles
 

• residual material located on pipes above a filling line and liquids leaking from the filling lines into the bottles with finished product
 

• unprotected rolls of blister cards stock and plastic blister film stored on the floor prior to use. 

We have reviewed your October 11, 2012 and January 15, 2013 responses and do not consider them to be adequate. We note that your corrective actions were documented in your response and will be verified during your next inspection; however, you did not provide any supporting information to demonstrate that the corrective actions have been implemented and as to whether you have established and are following written procedures for your manufacturing and packaging and labeling operations.

4. You failed to use equipment or utensils of appropriate design, construction, and workmanship to enable them to be suitable for their intended use, adequately cleaned, and properly maintained, as required by 21 CFR 111.27(a). Our investigators observed that production equipment is not suitably maintained. For example:
 

• The tube of the (b)(4) used to convey product from the screener to the (b)(4) cubic foot capacity (b)(4) Blender was torn. The inside of the tube was covered with various colors of powder.
 

• The (b)(4) encapsulator was repaired in various locations using clear tape, aluminum foil, and rubber bands. Two portable capsule dedusters were repaired using cardboard, clear tape, and rubber bands.
 

• On 9/13/2012, the exit port of the (b)(4) cubic foot capacity (b)(4) Blender contained chunks of "Stacker 2" capsule blend. The product was manufactured on 9/5/2012. 
 

We have reviewed your October 11, 2012 and January 15, 2013 responses and do not consider them to be adequate. We note that your corrective actions were documented in your response and will be verified during your next inspection; however, you did not provide any supporting information to demonstrate that the corrective actions have been implemented and as to whether you have established and are following written procedures for your equipment and utensils.

5. Although you have established a procedure for product complaints, your procedure lacks details and directions for obtaining and documenting product information, complaint information, and the review, disposition, and follow-up actions taken for product complaints. as required by 21 CFR 111.560.

From October 2011 through June 2012, you received 29 health related complaints, including a complaint of a heart attack, a possible allergic reaction, jittery, sick feeling, and a rash. You were unable to provide all this information to our investigators as required for product complaints. These products include Stacker 2 brand: XPLC; Stacker 2; Black Jax; Yellow Hornet; Extra Strength Xtra Energy Shot; Extra Strength 6 Hour Energy Shot; Extra Strength Extreme Energy Shot; and Stacker 3 brand XPLC, and Stacker 3.

We have reviewed your October 11, 2012 and January 15, 2013 responses and do not consider them to be adequate. While corrective measures were documented in your January 15, 2013 response, you did not provide supporting information to demonstrate that the products documented during the inspection were part of any corrective actions. Additionally, the procedures do not make clear that quality control personnel must review and approve decisions about whether to investigate a product complaint and review and approve the findings and follow-up action of any investigation performed, as required by 21 CFR 111.560.

Misbranding Violations:

6. Your "Stacker 2-6 Hour Power", "Stacker 2- Herbal Dietary Supplement (20 capsules)", "DIET APPULOSS", "Stacker 2- Extreme Energy Sugar Free", - "Stacker 2- 7-Phenyl Stack Diet and Energy", and "Stacker 2 Sleep Ease" products are misbranded within the meaning of section 403(q)(5)(F) of the Act (21 U.S.C. 343 (q)(S)(F)) in that the presentation of the nutrition information on the labeling does not comply with 21 CFR 101.36 and 21 CFR 101.4(g).
 

• Your "Stacker 2-6 Hour Power", "DIET APPULOSS", and "Stacker 2-7-Phenyl Stack Diet and Energy" product labels list "Other ingredients" within the supplement facts panel. These non-dietary ingredients should be listed outside and immediately below or immediately contiguous and to the right of the nutrition label in accordance with 21 CFR 101.4(g).
 

• Your "Stacker 2 - Extreme Energy Sugar Free" product label lists several ingredients, including Taurine, Glucuronolactone, and Caffeine, outside the nutrition label of the supplement facts panel. These dietary ingredients should be listed inside the supplement facts panel along with their quantitative amount by weight per serving in metric units in accordance with 21 CFR 101.36(b)(3).
 

• Your "DIET APPULOSS" and "Stacker 2- Herbal Dietary Supplement (20 capsules)" product labels fail to indent each of the component dietary ingredients under the proprietary blend dietary ingredients in accordance with 21 CFR 101.36(c)(2).
 

• Your "Stacker- Sleep Ease" product label lists Vitamin B12 in the wrong order. Vitamin B12, its quantitative amount by weight per serving, and percent of the daily value should be listed before sodium in accordance with 21 CFR 101.36(b)(2)(i)(B). 

7. "Your Stacker 2-6 Hour Power", "Stacker 2- Herbal Dietary Supplement (4 capsules)", "Stacker 2- Herbal Dietary Supplement (20 capsules)", "Stacker 2- 7-Phenyl Stack Diet and Energy", and "DIET APPULOSS" products are misbranded within the meaning of section 403(q)(1)(B) because they fail to declare the servings per container in accordance with 21 CFR 101.36(b)(1)(ii).

8. Your "Stacker 2- 7-Phenyl Stack Diet and Energy" product is misbranded within the meaning of section 403(q)(1)(A) because the serving size declared on the label is incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2.

The directions of use suggest the consumer take one 7 -phenyl stack capsule 1 hour prior to breakfast and one capsule prior to lunch, but the serving size lists 2 capsules. The serving size listed should be one capsule.

9. Your "Vitamin Shot D3", "DIET APPULOSS", and "Stacker 2 -7-Phenyl Stack Diet and Energy" products are misbranded within the meaning of section 403(i)(2) of the Act in that the products label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4(a) and (b).
 

• Your "Vitamin Shot D3" product label claims to contain "natural and /or artificial flavors" and claims to contain "Berry" as a flavor, but your ingredient list fails to declare the common or usual names of any flavorings used. 

• Your "DIET APPULOSS" and "Stacker 2- 7-Phenyl Stack Diet and Energy" product labels declare the dietary ingredients EGC, DL-C, EGCG, EC, OCG, and ECG, but these are not the common or usual name for these dietary ingredients.
 

10. Your "Stacker 2- Herbal Dietary Supplement (20 capsules)" product is misbranded within the meaning of Section 403(e)(1) of the Act [21 U.S.C. § 343 (e)(1)] in that it fails to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5.

11. Your "Stacker 2- Herbal Dietary Supplement (20 capsules)" product is misbranded within the meaning of section 403(y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement.

12. Your "Stacker 2- Extreme Energy Sugar Free!" product is misbranded within the meaning of 403(s)(2)(B) of the Act [21 U.S.C. § 343 (s)(2)(B)] because it does not include a statement of identity as a "dietary supplement" in accordance with 21 CFR 101.3(g).

The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. It is your responsibility to ensure that your firm and the products that you manufacture comply with the Act and FDA regulations.

You should take prompt action to correct the violations cited in this letter. Failure to promptly correct the violations specified above may result in enforcement action without further notice, including seizure and 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 re-inspection-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. Re-inspectionrelated 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)). 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 reinspection-related 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 the violations noted above, including an explanation of each step being taken to prevent their recurrence. Your response should include documentation of your corrective actions. If you cannot complete all corrective actions within fifteen working days, you should state the reason for the delay and the time within which you will complete 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, Attn: Erin McCaffery, Compliance Officer. If you have any questions regarding any issue in this letter, please contact Erin McCaffery at (973) 331-4993.
 

Sincerely,
/S/

Diana Amador-Toro
Director, New Jersey District