# FDA 483 - Chemtron Biotech, Inc - March 18, 2022

Source: https://www.keypedia.com/records/483/chemtron-biotech-inc/0a1eec23-3b69-4a67-94be-93b5756c5af0

> FDA 483 for Chemtron Biotech, Inc on March 18, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Chemtron Biotech, Inc
- Inspection Date: 2022-03-18
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Chemtron Biotech, Inc. in San Diego, CA, conducted from March 14-18, 2022, identified a significant issue regarding process validation. The firm failed to adequately validate a manufacturing process, specifically by not performing operational qualification for equipment used in producing in-vitro diagnostic test kits. This lapse indicates a potential risk to the quality and reliability of their finished IVD products.

## Related Officers

- [Juanj Wu](https://www.keypedia.com/people/juanj-wu/0d3e8970-b524-49f6-a307-079091b3c91d)
- [Rebecca L. Stephany](https://www.keypedia.com/people/rebecca-l-stephany/33f38e32-c0a6-4292-a515-ab3f6ca6503a)

Company: https://www.keypedia.com/companies/chemtron-biotech-inc/1d258f61-8b98-4426-8d08-891bf58674d4

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6