GMP Compliance Series: Part 4: Specifications That Improve Compliance

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 company has to both establish the required specifications and ensure the specifications are met. Another[…]

GMP Compliance Series: Part 3: Improving Batch Production Records

InstantGMP™ Compliance Series – Batch Production Records that Improve Compliance from Richard Soltero on Vimeo. 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[…]