# FDA 483 - Alva Prototypes Inc - December 19, 2023

Source: https://www.globalkeysolutions.net/records/483/alva-prototypes-inc/a9957434-a0bd-4c98-a9b5-a43e5c7715cb

> FDA 483 for Alva Prototypes Inc on December 19, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Alva Prototypes Inc
- Inspection Date: 2023-12-19
- Product Type: device
- Office Name: Philadelphia District Office
- Summary: An FDA inspection of Alva Prototypes Inc, a medical device manufacturer in Pottstown, PA, identified a significant quality system deficiency. The firm failed to document evaluations and remedial actions for out-of-calibration equipment, specifically a caliper used in production that was found to be out-of-calibration for an extended period. This indicates a lapse in maintaining proper control over measurement equipment critical for device quality.

## Related Officers

- [Investigator at US Food and Drug Administration](https://www.globalkeysolutions.net/people/brian-s-keefer/4fec578b-ca72-4d79-8634-3a9fe7ecd9a5)

Company: https://www.globalkeysolutions.net/companies/alva-prototypes-inc/f708f967-fef7-4bd8-8f5a-834de71ad954

Office: https://www.globalkeysolutions.net/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8