FDA 483 - Lupin Limited - March 29, 2023

This FDA Form 483 details multiple observations from an inspection of a pharmaceutical manufacturing facility.

**Facility and Operations:** The document refers to a facility of Lupin Limited, mentioning specific areas like the warehouse, QC Batch, Inspection area, manufacturing and packaging areas, Building, and a filling line room. Products include Solution Batch, Capsules, Tablets (USP mg, USP 1g), and other US-marketed drug products.

**Violations and Observations:**

* **Observation 1:** Investigations into out-of-specification (OOS) results for a Solution Batch (9-Month Long Term stability study) were inadequate. An OOS result for a test was found, but the investigation did not extend to other potentially affected drug products. The root cause identified (surface imperfections) was not reported during initial incoming material inspection. * **Observation 2 (Repeat):** The firm failed to thoroughly review unexplained discrepancies and OOS results. * **A.** Deviations/equipment failures during manufacturing and packaging were not consistently documented in batch records, investigated, or subjected to risk assessments and CAPAs. Out of 1695 breakdown notifications (Jan 2019-Mar 2023), only 41 were investigated. * **B.** Deviation investigations were not thorough, and appropriate actions were not taken. Examples include: * A foreign-filled capsule found in a Capsule Batch, supplied by