483
First Article IncFirst Article Inc – FDA 483, Jul 21, 2026
Record Details
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.
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ID · ed5cea39-f790-49d3-9d5e-0dd6b522aa78
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