FDA WARNING_LETTER - Akorn, Inc. - May 16, 2018

The FDA issued a Warning Letter to Akorn, Inc. following an inspection of their Decatur, IL drug manufacturing facility from April 9 to May 16, 2018. The letter identifies significant violations of current good manufacturing practice (CGMP) regulations, rendering their drug products adulterated.

Key violations include: 1. **Failure to prevent microbiological contamination (21 CFR 211.113(b))**: Observed poor aseptic behavior by operators (e.g., placing heads over open vials, excessive handling of sterile stopper bags, improper wiping), use of non-integral sterile glove and wipe packaging, and inadequate cleanroom design with smoke study deficiencies. The firm's response was deemed insufficient, lacking a comprehensive evaluation of affected batches and commitment to extensive aseptic process redesign. 2. **Inadequate facility design and control systems (21 CFR 211.42(c)(10))**: Deficiencies in environmental and personnel monitoring programs (e.g., lenient glove CFU limits, sanitizing hands before monitoring), and a deficient cleaning program where operators skipped steps and failed to properly sanitize equipment and surfaces. The firm's responses were inadequate, lacking scientific justification for limits and a thorough investigation into the scope of poor cleaning practices. 3. **Failure to follow a written stability testing program (21 CFR 211.166(a))**: Inability to ensure stability for acetylcysteine