# FDA 483 - Alfa Scientific Designs Inc - June 20, 2013

Source: https://www.globalkeysolutions.net/records/483/alfa-scientific-designs-inc/87ee3450-bd0f-4ccd-925b-da91c62bb5b0

> FDA 483 for Alfa Scientific Designs Inc on June 20, 2013. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Alfa Scientific Designs Inc
- Inspection Date: 2013-06-20
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Alfa Scientific Designs Inc. in Poway, CA, a medical device manufacturer, revealed significant deficiencies in their quality system. The firm failed to establish and maintain adequate procedures for monitoring and controlling validated process parameters, managing storage areas, and ensuring routine equipment calibration and maintenance. These observations indicate a need for improved procedural controls within the manufacturing operations.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/sarah-a-hassas/4f142d54-fc28-4bd5-82ad-7e6fa443688c)

Company: https://www.globalkeysolutions.net/companies/alfa-scientific-designs-inc/fff83e5b-3a70-4552-acdb-df6af7bdd62e

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