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Gaspari Nutrition is the latest firm to be in breach of Good Manufacturing Practice (GMPs), regulations after inspections in 2010 revealed adverse event reporting (AER) breaches. The FDA ‘483? inspections that occurred over a five week period between September 27 – November 1, 2010, found the maker of PlamaJet and SuperPump products did not follow its own AER procedures in regard to seven separate complaints. For those two products, the FDA said the company did not perform analysis of the complaints it classified as “minor discomfort”.
For a product called Mitotropin, complaints were classified as “Serious Personal Injury Claims”, but Gaspari did not have them, “referred to the Senior Manager of Distributor Services or have the Senior Manager interview the complainants, as called for in your firm’s written procedures.” There was also a Serious Personal Injury complaint for SuperPump. Gaspari responded to the FDA in November, 2010, saying it was rectifying the problem, but the FDA said the problems had not been resolved and added that it would be evaluating, “whether your firm has established and followed written procedures for reviewing product complaints during our next inspection.”
Blood In Your Shit?
The Adverse Event Reports included sores inside a consumer’s mouth, as well as, “chest pain and abnormal kidney levels” after product consumption. Gaspari also, “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.”
A Gaspari spokesperson said the company had no comment on the letter
For a product called Mitotropin, complaints were classified as “Serious Personal Injury Claims”, but Gaspari did not have them, “referred to the Senior Manager of Distributor Services or have the Senior Manager interview the complainants, as called for in your firm’s written procedures.” There was also a Serious Personal Injury complaint for SuperPump. Gaspari responded to the FDA in November, 2010, saying it was rectifying the problem, but the FDA said the problems had not been resolved and added that it would be evaluating, “whether your firm has established and followed written procedures for reviewing product complaints during our next inspection.”
Blood In Your Shit?
The Adverse Event Reports included sores inside a consumer’s mouth, as well as, “chest pain and abnormal kidney levels” after product consumption. Gaspari also, “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.”
A Gaspari spokesperson said the company had no comment on the letter
