FDA 483 - NATCO Pharma Limited - October 18, 2023

This FDA Form 483 details multiple observations from an inspection, primarily concerning equipment cleaning, quality control, data integrity, and aseptic processing.

**Observation 1:** Equipment and utensils are not cleaned and maintained to prevent contamination. * Non-dedicated equipment (ID: VS/034) used for potent drug products showed thick build-up of materials, even when in "CLEANED" status. Swab samples revealed drug substances up to 800 times the acceptance limit, indicating cross-contamination risk. Unknown peaks were also present. * Another piece of equipment (ID: T/020) also showed material build-up in "CLEANED" status, with swab samples revealing drug substances up to 117 times the acceptance limit. * Field Alerts were reported for several tablets due to potential cross-contamination. * Impact assessments for cleaning and new equipment installation were inadequate, with a delayed Field Alert submission (over nine months). * Standard Test Procedures (STPs) for swab sample analysis are deficient, lacking mention of swab blank solution preparation (73 out of [REDACTED] STPs), type of swab stick (31 out of [REDACTED] STPs), and stability of swab samples/solutions (9 products, 25 STPs). * Insufficient "correct" swab sticks were available for 41 out of [REDACTED] drug products.