# FDA 483 - North American Science Associates Inc - July 24, 2025

Source: https://www.keypedia.com/records/483/north-american-science-associates-inc/9c1b114b-e57e-4c73-b262-15776d393449

> FDA 483 for North American Science Associates Inc on July 24, 2025. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: North American Science Associates Inc
- Inspection Date: 2025-07-24
- Product Type: other
- Office Name: Los Angeles District Office
- Summary: North American Science Associates, LLC in Irvine, CA, received a Form 483 citing significant deficiencies in their control laboratory operations. Observations included inadequate maintenance of aseptic processing equipment, failures in environmental and personnel monitoring, and a lack of thorough investigation into discrepancies. Additionally, the firm was cited for issues with annual record reviews and for not making required documents readily available during the inspection.

## Related Officers

- [Rowena S. Nguyen](https://www.keypedia.com/people/rowena-s-nguyen/ae39318e-1653-467c-94cc-26f8929441ac)
- [Lillian S. Wu](https://www.keypedia.com/people/lillian-s-wu/b1f6643c-ac01-43e5-8ce2-e6f4fdba9d35)
- [Pharmaceutical investigator](https://www.keypedia.com/people/bryan-a-galvez/d1e52abc-5b56-4ffb-af22-90e6733fb73a)

Company: https://www.keypedia.com/companies/north-american-science-associates-inc/4d7ae3a6-adaf-49ae-becb-ab842da002d9

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b