FDA 483 - Lupin Limited - January 25, 2019

This FDA Form 483 details multiple observations from an inspection, primarily concerning quality control, data integrity, and personnel training.

**Observation 1** highlights a failure to thoroughly review unexplained discrepancies and Out-of-Specification (OOS) results. This includes: * **Moxifloxacin Ophthalmic Solution USP 0.5% (Batch H800393):** An OOS for Related Substances (impurity exceeding specification) was identified. The impurity was re-categorized as (b)(4) formed due to (b)(4) on the product label. A health-hazard assessment, acknowledging (b)(4) as an eye irritant, was delayed. Deficiencies include failure to re-train analysts, unscientific justification for analyzing retention samples quarterly, and limited market action (recall only for OOS batch H800393 while other impacted batches remained on the market). A CAPA to develop an analytical method for (b)(4) on labels was closed by procuring new labels without (b)(4), without an in-house verification test or supplier audit. The R&D evaluation did not explain why only the OOS batch was impacted. No attempt was made to quantify (b)(4) on labels. A formal analytical method re-validation for (b)(4) in the finished product has not been performed, and a limit for (b)(4) is not established. The current shelf