FDA WARNING_LETTER - Hetero Labs Limited Unit V - December 16, 2016

The FDA issued a Warning Letter to Hetero Labs Limited, Unit V, following an inspection from December 7-16, 2016, identifying significant CGMP violations for finished pharmaceuticals, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations include: 1. **Insufficient Investigations (21 CFR 211.192):** The firm failed to thoroughly investigate unexplained discrepancies or OOS results. For example, a customer complaint regarding dissolution failure for (b)(4) mg (b)(4) tablets (lot (b)(4)) was inadequately investigated, with inconsistent conclusions and a failure to identify the root cause or scope of the issue. The FDA requires updated dissolution testing, a retrospective review of all investigations and manufacturing process validations for U.S.-bound products, and a plan for future thorough investigations. 2. **Equipment Cleaning and Maintenance (21 CFR 211.67(a)):** Investigators observed "clean" equipment with colored residue and in poor condition, such as (b)(4) PDE-2095 having white residue and a damaged gasket. The firm's explanation was deemed insufficient. The FDA demands sampling procedures and analytical methods for residues, procedures for gasket installation/maintenance, an assessment of similar gaskets, and an overall assessment of the cleaning program, including cleaning validation studies. 3.