FDA 483 - Ajinomoto Althea, Inc. - January 16, 2023

The FDA Form 483 documents observations from an inspection, highlighting deficiencies in quality oversight, facility and equipment maintenance, and quality control unit procedures.

**Quality Oversight of Validation Activities:** * The Filling capping machine validation (VAL-1764, rev. 1.0, effective 09/23/2021) for Container Closure Integrity Testing used only one batch run instead of three. * The Quality Control Microbiology Laboratory’s cGMP material ambient storage room (Rm. 902) is not qualified for 20-25 degrees Celsius.

**Facility and Equipment Maintenance:** * SOP.1021, rev. 5.0 (effective 05/31/2021) for Cleaning and Sanitization directs disinfectant contact time, but this contact time is not validated by studies VAL-1209, rev. 3.0 (effective 07/14/2022) or S-R-363, rev. 1.0 (effective 01/28/2015). SOP-1021 also fails to direct the capture of exposure time in cleaning records. * The Pre-wash Room (Rm. 1015) lacks a trap and a microbial maintenance and monitoring program. * Equipment used in drug product production is not maintained, exemplified by