FDA 483 - Daewoong Pharmaceutical Co. Ltd. (Hyangnam factory) - November 17, 2017

The FDA Form 483 details multiple deficiencies observed during an inspection. The facility failed to thoroughly investigate unexplained discrepancies, specifically regarding black particles found in drug product batches (Building ) and development batches (Building ), exceeding acceptance criteria. No investigation was conducted to determine the source or recurrence, and particle size classification per SOP NPR03-066 was not documented.

A deviation (17017) for incorrect lot number assignment led to a canceled CAPA (NCP 17023), with no retraining or preventive measures taken. Temperature distribution tests for an anaerobic chamber failed requalification, attributed to aging equipment, with a corrective action of designating a specific work area.

Specifications for critical reagents are inadequate; SOP NQC01-006 does not require specificity verification for antibodies used in drug substance identity testing. Endotoxin method verification for drug substance is deficient, as the actual drug substance was not used.

Aseptic processing areas have deficient environmental monitoring (EM) systems. EM sample collection is not recorded at the time of collection, raw data on erasable worksheets is not retained, and EM samples are not tracked like other QC samples. Cleaning and disinfection procedures (NPE05-046, NP503-006) are inadequate, with masking tape residue not assessed and disinfectant contact times inconsistent with validation reports.

Procedures for preventing microbiological contamination are lacking, including validation of aseptic processes. Airflow pattern testing