Warning Letters & 483’s
Omega & Delta Co., Inc. :
Insanitary Conditions & CGMP Violations
Nephron SC Inc. :
Failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes
Glenmark Pharmaceuticals Limited:
Failed to establish and follow required laboratory control mechanisms (21 CFR 211.160(a))