SpecGx LLC – FDA EIR, Jan 25, 2019

An FDA routine surveillance inspection of SpecGx LLC (DBA: Mallinckrodt Inc.) in Greenville, IL, was conducted from January 22-25, 2019. The inspection focused on the company’s manufacturing of Active Pharmaceutical Ingredients (APIs), specifically bulk acetaminophen and ibuprofen, in accordance with CPGM 7356.002F and Q7 Good Manufacturing Practices. The inspection identified a significant violation, resulting in a one-item FDA Form 483. The primary issue was the failure to consistently document a critical inspection required by a Corrective and Preventive Action (CAPA) plan in the batch production records. This CAPA mandated documentation of the auger flight position inspection at the end of each batch for the Compap Coarse L product, following prior complaints of metal particle contamination. Review of six batch records showed four lacked this documentation, and a broader internal review revealed 19 lots without documentation in either batch records or equipment logs, though these were bracketed by documented inspections. As immediate responses, management planned to issue a temporary batch production record to ensure consistent documentation and will revise permanent records upon full equipment repair. They also initiated a '5 Why' analysis to investigate the root cause of this oversight. The company was reminded of its responsibilities to comply with the Food, Drug, and Cosmetic Act.