FDA 483 - Jubilant Generics Limited - March 12, 2021

This FDA Form 483 details multiple observations from an inspection, primarily concerning equipment cleaning, validation, and data integrity.

**Observation 1** highlights that equipment and utensils are not adequately cleaned, maintained, and sanitized, leading to potential drug product contamination. Specific instances on March 2nd, 2021, include residue on non-dedicated (b)(4) equipment PR/(b)(4)/002, (b)(4) residue on non-dedicated (b)(4) compression machine PR/TCP/011, (b)(4) residue and particles on non-dedicated (b)(4) machine PR/(b)(4)/001, rust-like surfaces on non-dedicated (b)(4) machine PR/(b)(4)/004, and stains on non-dedicated (b)(4) machine DL(b)(4)/001. These machines are used for various drug products, including (b)(4), (b)(4), and (b)(4), with batches distributed to the US market. Additionally, the "Receipt, Inspection, Cleaning, Usage, Polishing and Disposal of Punches and Dies" procedure (PR020-11) is inadequate, failing to ensure proper maintenance and accounting for wear of frequently used punches, with observed edge-wear, (b)(4), and (b)(4) on lower punches. Punch and die re-inspection intervals lack