Problems with Deviations Himalayan Institute, a dietary supplement manufacturer in NY, was issued a warning letter for violations of GMP regulations. The FDA noted in their investigations that several of the company’s batch production records showed deviations from the Master…
Problems with In-Process Control A dietary supplement manufacture,Health One Pharmaceuticals, Inc. received a warning letter in part because they did not establish in-process specification in their Master Manufacturing Record. This firm checked the weight of capsules throughout manufacturing, but they…
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…
The Food and Drug Administration (FDA) started enforcing Good Manufacturing Practice requirements for all Dietary Supplement manufacturers in 2010. Since then, they have published the results of their inspections and the warning letters they issue when manufacturers fail to come…
Posted by Rick Soltero The FDA inspections of dietary supplement manufacturers have resulted in 1 in 4 producers getting a Warning Letter that could shut down their business. We have analyzed the inspection notices from these manufacturers and wrote this…