Inspections, Compliance, Enforcement, and Criminal Investigations
Gaspari Nutrition, Inc. 3/2/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Waterview Corporate Center
Telephone (973) 331-4905
March 2, 2011
VIA OVERNIGHT DELIVERY
Mr. Richard Gaspari
575 Prospect Street, Suite 230
Lakewood, NJ 08701
File # 11-NWJ·11
Dear Mr. Gaspari:
From September 27 - November 1, 2010 the U.S. Food and Drug Administration (FDA) inspected your firm located at 575 Prospect Street in Lakewood, New Jersey. Your firm holds and distributes dietary supplements. Our investigators found serious violations of 21 CFR Part III, Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements. 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 the products have been prepared, packed, or held under conditions that do not meet CGMP regulations for dietary supplements. These observations were presented to you in a FDA-483 at the conclusion of our inspection on November 1, 2010.
Violations observed at your facility include:
1. You failed to follow written procedures for the review and investigation of product complaints, as required by 21 CFR 111.553. Specifically, your employees did not follow your written procedures entitled "Gaspari Nutrition Consumer Claim Policy and Procedure" for the following products and seven complaints:
• A complaint regarding your PlasmaJet product was received on 6/25/10 and classified as a "Minor Discomfort." However, you did not perform (b)(4) analysis reports of product complaint trends, as called for in your firm's written procedures.
• Complaints regarding your Mitotropin product were received on 8/19/09, 12/16/09, 1/26/10 and 8/23/10 and classified as "Serious Personal Injury Claims." However, you did not refer the complaints to the Senior Manager of Distributor Services or have the Senior Manager interview the complainants, as called for in your firm's written procedures.
• Complaints regarding your SuperPump product were received on 8/17/09 and 6/9/10 and classified as "Minor Discomfort" and "Serious Personal Injury Claim," respectively. However, you did not perform (b)(4) analysis reports. for the "Minor Discomfort" complaint and did not refer the "Serious Personal Injury" complaint to the Senior Manager of Distributor Services, as called for in your firm's written procedures.
Your November 10, 2010 response states that you are in the process of implementing a new Product Compliant!Adverse Event Reporting Standard Operating Procedure (SOP). Your response is inadequate as it fails to address the violations listed above. We will evaluate whether your firm has established and followed written procedures for reviewing product complaints during our next inspection.
2. You failed to have qualified employees review product complaints and failed to have your quality control personnel review and approve decisions about whether to investigate a product complaint, as required by 21 CFR 111.560(a) and 111.560(b). Specifically, your firm's designated qualified employee did not review four of seven complaints reported regarding your PlasmaJet, SuperPump 250 and Mitotropin products. These complaints included sores inside a consumer's mouth, as well as, "chest pain and abnormal kidney levels" after product consumption.
Your November 10, 2010 response indicates that your firm has retained the services of (b)(4) to address your "serious" adverse events and to conduct a training program in adverse event reporting for your employees within (b)(4). Your response is inadequate as it fails to address the violations listed above. We will evaluate your review of product complaints during our next inspection.
3. You failed to investigate product complaints as required by 21 CFR 111.560(a)(2). For example, you did not investigate the complaint of a consumer who contacted your firm regarding having bloody stools and excessive amounts of red color in their toilet water following consumption of your SuperPump dietary supplement product.
This letter is not an all-inclusive list of violations at your facility. It is your responsibility to ensure that your firm and the products you market comply with the Act and its implementing regulations. Failure to take prompt action to correct the violations cited in this letter may result in enforcement action without further notice including, but not limited to seizure of violative products and/or injunction.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific actions you have taken to correct the violations noted above. Your response should include an explanation of the actions you have taken to prevent the recurrence of violations and any supporting documentation. You should also include in your response a status update on the implementation of the corrective actions outlined in your November 10, 2010 response to the FDA-483 If you cannot complete all corrections within fifteen days, you should explain the reason for your delay and state when you will correct any remaining violations.
Your response should be sent to the following address: U.S. Food and Drug Administration, 10 Waterview Blvd., Parsippany, New Jersey 07054, Attn: Joseph F. McGinnis R.Ph, Compliance Officer.
New Jersey District