# FDA 483 - Creation Technologies - March 11, 2022

Source: https://www.keypedia.com/records/483/creation-technologies/1324bca5-5f0e-420d-9c77-3113e408a566

> FDA 483 for Creation Technologies on March 11, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Creation Technologies
- Inspection Date: 2022-03-11
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of IEC Electronics in Newark, NY, conducted from March 10-11, 2022, identified one observation. The firm was cited for not adequately conducting and monitoring production processes to ensure device conformity to specifications. Specifically, calibration of the microphone and sound chamber for the Sound Wave Sontro SWH #99000-02 was not properly performed prior to each production run.

## Related Documents

- [483 - 2019-02-14](https://www.keypedia.com/records/483/creation-technologies/de2418b4-68d0-47be-a15e-e4ca51867191)
- [WARNING_LETTER - 2020-03-05](https://www.keypedia.com/records/warning_letter/creation-technologies/5cd286bb-c886-4415-b2f4-587a3753e792)

## Related Officers

- [investigator](https://www.keypedia.com/people/wendy-m-stone/715b04f5-3949-4ca6-9bda-26ff611e9354)

Company: https://www.keypedia.com/companies/creation-technologies/5c6318a9-84e4-4023-b17a-a87f182c4325

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961