# First Article Inc – FDA 483, Jul 21, 2026

Source: https://www.keypedia.com/records/483/first-article-inc/ed5cea39-f790-49d3-9d5e-0dd6b522aa78

> FDA 483 for First Article Inc on July 21, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: First Article Inc
- Inspection Date: 2026-07-21
- Product Type: device
- Office Name: Philadelphia District Office
- Summary: An FDA inspection of First Article Inc., a medical device manufacturer in Souderton, PA, revealed a significant issue with equipment calibration. Specifically, a micrometer used for in-process testing of medical device components lacked documented calibration records prior to 2025, making its calibration status undeterminable. This indicates a potential lapse in quality control for critical measuring equipment.

## Related Officers

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

Company: https://www.keypedia.com/companies/first-article-inc/7f01a45b-90dd-41a6-bd57-cfd6d6632b41

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