# FDA 483 - Ajinomoto Althea, Inc. - September 20, 2023

Source: https://www.keypedia.com/records/483/ajinomoto-althea-inc/189c64ec-06f0-442c-9aaf-eb9ea48f6a0b

> FDA 483 for Ajinomoto Althea, Inc. on September 20, 2023. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Ajinomoto Althea, Inc.
- Inspection Date: 2023-09-20
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Ajinomoto Althea, Inc. DBA Ajinomoto Bio-Pharma Services in San Diego, CA, was cited for significant deficiencies in microbial cross-contamination control and aseptic processing procedures. The inspection also found inadequate complaint investigations regarding particulate matter in finished drug products. These issues indicate a lack of robust quality control and adherence to sterile manufacturing practices.

## Related Documents

- [483 - 2023-01-16](https://www.keypedia.com/records/483/ajinomoto-althea-inc/14059599-d17b-4422-a4b2-70d7caea5b4e)
- [483 - 2025-05-09](https://www.keypedia.com/records/483/ajinomoto-althea-inc/460eb7ec-a1f2-489e-af6c-54a4f2adef31)
- [483 - 2023-02-09](https://www.keypedia.com/records/483/ajinomoto-althea-inc/580fc4cc-211e-489a-8466-337a0c433bff)
- [483 - 2023-01-16](https://www.keypedia.com/records/483/ajinomoto-althea-inc/31d386f5-e5ea-4cf9-b563-54c74ade61ef)
- [483 - 2019-08-07](https://www.keypedia.com/records/483/ajinomoto-althea-inc/f4a2b512-1b50-4605-a609-304be78baf30)

## Related Officers

- [Yi Wang, PhD, Staff Fellow](https://www.keypedia.com/people/yi-wang-phd-staff-fellow/5a38ae27-971d-41cc-be0f-7398c4228e7f)
- [Cai-huan Qin, PhD, CSO](https://www.keypedia.com/people/cai-huan-qin-phd-cso/63aa808d-74bd-491e-bdc4-c615539aab14)
- [investigator](https://www.keypedia.com/people/cassandra-l-abellard/e27aef11-adc6-449b-b7a8-f4c419549467)

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

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd