Company: Nutra Med Inc.
Product: Over-the-counter and prescription drug products
Date: 10/2/03
Failure to maintain records of the inspections of automatic, mechanical or electronic equipment, including computers or related systems. [211.68(a)].
For example, equipment qualification was not adequate for the following drug manufacturing equipment: Double Cone Blender (_____ kg.), Fitzpatrick Fitzmill Comminuting Machine, Coating Pans, Kent Pony Mixer/Granulator, Double Cone Blender (20 kg.), Electronic Tablet/Capsule Counter, Strokes 16 Station Tablet Press, Drying Room, and Shimadzu UV-Vis HPLC (LC-4), Hotpack Accelerated Stability Chamber.
FDA District: New Jersey District Office
