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

Source: https://www.keypedia.com/records/warning_letter/akorn-inc/d07fe095-26cd-49a4-a448-3b6512830353

> FDA WARNING_LETTER for Akorn, Inc. on May 16, 2018. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Akorn, Inc.
- Inspection Date: 2018-05-16
- Product Type: Drugs
- Office Name: Detroit District Office
- Summary: 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

## Related Documents

- [483 - 2009-11-10](https://www.keypedia.com/records/483/akorn-inc/f60cb2d9-b6f6-4c05-8afa-ee130626e106)
- [WARNING_LETTER - 2012-10-02](https://www.keypedia.com/records/warning_letter/akorn-inc/64c1b9d7-84e6-40ae-92cd-c562e847494d)
- [483 - 2009-06-30](https://www.keypedia.com/records/483/akorn-inc/d6866295-ee51-4e24-9c6a-65324614527b)
- [483 - 2010-09-17](https://www.keypedia.com/records/483/akorn-inc/d583d7c7-6c57-4ec6-8073-4c21483136b9)
- [483 - 2018-05-16](https://www.keypedia.com/records/483/akorn-inc/5136e44f-4aca-4b08-9dc5-7fe10577623e)

## Related Officers

- [Investigator](https://www.keypedia.com/people/russell-k-riley/4813d9c2-52a3-4eba-8606-d4be5e03fd04)
- [Associate Director](https://www.keypedia.com/people/jeffrey-d-meng/55543677-bd74-4cc5-8a2a-e14afb91d338)

Company: https://www.keypedia.com/companies/akorn-inc/91871042-8cde-411b-b464-09797e0b23db

Office: https://www.keypedia.com/offices/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03