GMP Problems The identification of the key issues in product complaints is a tool for overall quality improvement. The primary principle is that the manufacturer must assume responsibility for the quality of their products to ensure that they are fit…
GMP Problems The FDA has issued a number of warning letters FDA issued Warning Letters for GMP violations of Dietary Supplement Health and Education Act where they cited failures of the firm’s supplier and vendor certification programs. They issued one…
Pharmacist’s Ultimate Health of St. Paul, Minnesota agreed to a consent decree to cease their unlawful distribution of unapproved new drugs and adulterated dietary supplements. They have to stop distributing their products until all disease claims are removed from their…
FDA inspectors noted Oza failed to set specifications for identity, purity, strength and composition for each component used in the manufacturing of its dietary supplement product. Such specifications were also not established for the finished product. The agency reminded the…
A dietary supplement company called Milk Specialties Global got an FDA warning letter after an inspection of its plant in Wautoma, Wis. According to the FDA, the company kept incomplete records of its batches of supplements and failed to record…
Posted by Rick Soltero A review of warning letter trends revealed that many are issued because firms not keeping proper Master Manufacturing Records (MMR). An example is in the Warning Letter issued to United Nutrition Labs, Inc in July. The…
GMP Manufacturing of Dietary Supplements Not everyone in the dietary supplement business is aware that the FDA now requires Good Manufacturing Practices (GMPs) in manufacturing, packaging, labeling, or holding operations for dietary supplements. Any company involved has to establish and to…