# FDA 483 - Scientific Pharmaceuticals, Inc. - January 09, 2020

Source: https://www.keypedia.com/records/483/scientific-pharmaceuticals-inc/3481cbbc-16b3-41df-af3d-c2875d50f322

> FDA 483 for Scientific Pharmaceuticals, Inc. on January 09, 2020. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Scientific Pharmaceuticals, Inc.
- Inspection Date: 2020-01-09
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Scientific Pharmaceuticals, Inc. in Pomona, CA, a medical device manufacturer, revealed significant deficiencies in design control documentation. Observations included inadequate documentation of design input requirements for a Class II medical device and a lack of documented design risk analysis results. These issues indicate a failure to properly establish and maintain design controls for new product development.

## Related Officers

- [Sonya L. Karsik](https://www.keypedia.com/people/sonya-l-karsik/c24603b9-5ca0-46f5-861a-b367155b0def)

Company: https://www.keypedia.com/companies/scientific-pharmaceuticals-inc/39da0f9c-8424-48a8-a6d7-f00f175bbcc9

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