# FDA 483 - Alfa Wassermann, Inc. - September 27, 2022

Source: https://www.keypedia.com/records/483/alfa-wassermann-inc/6e0b2e77-6aa2-462d-923f-1332353c13df

> FDA 483 for Alfa Wassermann, Inc. on September 27, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Alfa Wassermann, Inc.
- Inspection Date: 2022-09-27
- Product Type: device
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Alfa Wassermann, Inc. in West Caldwell, NJ, a manufacturer of clinical chemistry systems, revealed significant deficiencies in their quality system. Observations included inadequate device history records, insufficient procedures for manufacturing material control, and a lack of established processes for equipment calibration, complaint handling, statistical techniques, process controls, and employee training. These issues indicate a broad failure to ensure devices are manufactured and controlled in accordance with established quality system requirements.

## Related Officers

- [Frank J. Marciniak](https://www.keypedia.com/people/frank-j-marciniak/6995351a-6afc-4056-9692-d4aeb711dd92)

Company: https://www.keypedia.com/companies/alfa-wassermann-inc/14a9e35f-9315-4d5f-9380-7c5dc24f7e01

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248