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

Source: https://www.keypedia.com/records/483/ajinomoto-althea-inc/14059599-d17b-4422-a4b2-70d7caea5b4e

> FDA 483 for Ajinomoto Althea, Inc. on January 16, 2023. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ajinomoto Althea, Inc.
- Inspection Date: 2023-01-16
- Product Type: Devices
- Office Name: Division of Biotechnology Manufacturing
- Summary: 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

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## Related Officers

- [Consumer Safety Officer (Inspector)](https://www.keypedia.com/people/christopher-r-czajka/42defbf3-ea06-4090-8d51-7da2b07d9e84)
- [Investigator](https://www.keypedia.com/people/michael-r-shanks/dd24952b-4309-451e-afe8-f68892cd7bac)
- [Regulatory Scientist at FDA](https://www.keypedia.com/people/yi-wang/f5355ae0-ae28-452f-829a-786b7ebc4791)

Company: https://www.keypedia.com/companies/ajinomoto-althea-inc/75fb5ea8-b86f-45c1-946e-80c73765f544

Office: https://www.keypedia.com/offices/division-of-biotechnology-manufacturing/3e3018f1-aa48-4010-a554-96f557f17c55