FDA Warns Facilities in Violation of CGMP Rules

The U.S. Food and Drug Administration (FDA) has been busy distributing warning letters to those in violation of the Current Good Manufacturing Practice (CGMP) rules. The recent recipients of these particular warning letters include dietary supplement distributer Gaspari Nutrition Inc. and supplement manufacturer Rasi Laboratories.

In a letter dated March 2, 2011, the FDA commented on a number of violations that were observed at a Gaspari Nutrition facility in Lakewood, New Jersey. FDA inspectors cited a number of serious violations that included the adulteration of products due to the malpractice of manufacturing, packaging, labeling, and holding operations. Products that were prepared, packed, or held at this facility failed to meet CGMP standards.

The letter to Gaspari Nutrition Inc. also cited the companies deliberate neglect to properly investigate complaints regarding products like PlasmaJet, Mitotropin, and SuperPump.

In a second warning letter dated February 17, 2011, the FDA addressed a number of violations observed at Rasi Laboratories in Somerset, New Jersey. Among the serious violations cited was a neglect to establish specifications for identity, purity, strength, and composition in Melatonin 20 Capsules before they were shipped.

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