FDA WARNING_LETTER - Acino Products, LLC - June 12, 2019

The FDA inspected Acino Products, LLC, a drug manufacturing facility in Hamilton, NJ, from May 28 to June 12, 2019, identifying significant violations of current good manufacturing practice (CGMP) regulations (21 CFR parts 210 and 211). The facility's drug products are deemed adulterated.

Key violations include: 1. **Facility Maintenance (21 CFR 211.58):** Dislodged and missing ceiling tiles were observed directly above manufacturing equipment for bisacodyl suppositories, posing a contamination risk. The firm's response was inadequate, lacking evidence of repairs and a comprehensive CAPA plan. 2. **Equipment Cleaning and Maintenance (21 CFR 211.67(a) and (b)):** Non-dedicated filling equipment was found filthy with residue. Cleaning procedures for dedicated equipment lacked validation data, and a different cleaning agent was used than specified. Cleaning logs were unavailable. A temperature control device on a suppository filling machine was taped and plastic-wrapped, lacking assurance of temperature maintenance. Equipment maintenance logs were also missing. These cleaning deficiencies are repeat observations from a 2017 inspection. 3. **Laboratory Records and Data Integrity (21 CFR 211.194(a)):** The firm could not provide test results to support microbiological testing on Certificates of Analysis (COAs) for bisac