Pan Drugs Ltd. – FDA Warning Letter, Jul 18, 2014

On September 2, 2015, the FDA issued a Warning Letter to Pan Drugs Limited following a July 14-18, 2014, inspection of their pharmaceutical manufacturing facility in Nandesari, India. The inspection revealed significant deviations from current Good Manufacturing Practice (CGMP) for Active Pharmaceutical Ingredients (APIs), rendering their APIs adulterated under Section 501(a)(2)(B) of the FD&C Act.

Key violations included: 1. **Facility Maintenance:** Holes in walls and roof allowing pigeon access, and gaps in outside walls for piping/air ducts, leading to potential contamination. The firm continued manufacturing despite recognizing disrepair. 2. **Equipment Maintenance:** Rust, dirt, lubrication leaks, and exposed insulation on/around open drug manufacturing equipment. The firm was under renovation during a previous 2011 inspection with similar commitments. 3. **Data Integrity:** Incomplete analytical testing protocols for a specific API lot, lacking heavy metals analysis, analyst names for residual solvents, and secondary review of results.

The firm's August 4, 2014, response was deemed insufficient. The FDA requested photographic evidence of facility renovation, a proactive maintenance plan, and a list of all U.S.-distributed lots within expiry, indicating if they lacked complete testing or secondary review. The FDA recommended engaging a third-party CGMP consultant due to continuing issues.

Until