# FDA 483 - ARCH-Blandon - February 07, 2020

Source: https://www.keypedia.com/records/483/arch-blandon/1dfc1675-d229-42f3-9d44-1df26b8ec2d8

> FDA 483 for ARCH-Blandon on February 07, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ARCH-Blandon
- Inspection Date: 2020-02-07
- Product Type: device
- Office Name: Philadelphia District Office
- Summary: During an inspection of Ipsmac Machine Co Inc in Blandon, PA, a medical device manufacturer, the FDA observed a significant issue related to equipment calibration and documentation. The firm failed to document evaluations and remedial actions for out-of-calibration equipment, specifically a digital indicator used for in-process testing that was out of calibration for three months. This indicates a lapse in quality system controls regarding equipment maintenance and record-keeping.

## 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/arch-blandon/ee8b1783-c91a-4ece-9bac-d69a50125c77

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