The U.S. Food and Drug Administration (FDA) has inspected Gaspari Nutrition, Inc.
firm located at 575 Prospect Street in Lakewood, New Jersey. The firm holds and distributes dietary supplements. The investigators have 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 has caused the 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 the products have been prepared, packed, or held under conditions that do not meet CGMP regulations for dietary supplements. These observations were presented to the company in a FDA-483 at the conclusion of the inspection on November 1, 2010.
Violations observed at Gaspari Nutrition’s facility include:
1. The company has failed to follow written procedures for the review and investigation of product complaints, as required by 21 CFR 111.553. Specifically, the employees did not follow the written procedures entitled "Gaspari Nutrition Consumer Claim Policy and Procedure" for the following products and seven complaints:
• A complaint regarding PlasmaJet product was received on 6/25/10 and classified as a "Minor Discomfort." However, the company did not perform (b) (4) analysis reports of product complaint trends, as called for in the firm's written procedures.
• Complaints regarding 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, the company did not refer the complaints to the Senior Manager of Distributor Services or have the Senior Manager interview the complainants, as called for in the firm's written procedures.
• Complaints regarding the SuperPump product were received on 8/17/09 and 6/9/10 and classified as "Minor Discomfort" and "Serious Personal Injury Claim," respectively. However, the company 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 the firm's written procedures.
The November 10, 2010 response states that company was in the process of implementing a new Product Compliant! Adverse Event Reporting Standard Operating Procedure (SOP). The response is inadequate as it fails to address the violations listed above. FDA will be evaluating whether the firm has established and followed written procedures for reviewing product complaints during FDA’s next inspection.
2. The company has failed to have qualified employees review product complaints and failed to have the 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, the firm's designated qualified employee did not review four of seven complaints reported regarding the 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.
The November 10, 2010 response indicates that the firm has retained the services of (b)(4) to address the "serious" adverse events and to conduct a training program in adverse event reporting for the employees within (b)(4). The response is inadequate as it fails to address the violations listed above. FDA will evaluate the review of product complaints during our next inspection.
3. The company has failed to investigate product complaints as required by 21 CFR 111.560(a) (2). For example, the company did not investigate the complaint of a consumer who contacted the firm regarding having bloody stools and excessive amounts of red color in their toilet water following consumption of the SuperPump dietary supplement product.
In the warning letter issued by FDA it has not listed all-inclusive list of violations at the facility. FDA has also mentioned that it is the responsibility of Gaspari Nutrition to ensure that the firm and the products marketed comply with the Act and its implementing regulations. Failure to take prompt action to correct the violations cited in the letter may result in enforcement action without further notice including, but not limited to seizure of violative products and/or injunction.
FDA has asked Gaspari Nutrition to respond in writing to the warning within fifteen (15) working days from the receipt of the letter.