Coupler Enterprises – FDA Warning Letter, Mar 10, 2020

On September 15, 2020, the FDA issued a Warning Letter to Coupler Enterprises following an inspection from February 26 to March 10, 2020. The inspection revealed significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, rendering the drug products adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations include: 1. **Inadequate Inspection of Packaging and Labeling Facilities (21 CFR 211.130(e)):** The investigator observed various tablets and capsules on and under packaging machinery despite batch records indicating line clearance and cleaning. This increases the risk of drug product mix-ups. The firm's response lacked a sufficient line clearance SOP and detailed cleaning schedule. 2. **Failure to Establish Adequate Cleaning and Maintenance Procedures (21 CFR 211.67(b)):** The firm could not scientifically justify the selection of drug products for cleaning validation studies, choosing "most powdery" products instead of those based on scientific rationale. 3. **Quality Control Unit Failure (21 CFR 211.22):** The Quality Unit (QU) failed to adequately oversee drug product manufacture, including not investigating 11 deviations as per their SOP and not qualifying equipment like the air compressor.

The FDA requires corrective actions, including providing detailed SOPs for line clearance