# FDA 483 - Creation Technologies - February 14, 2019

Source: https://www.keypedia.com/records/483/creation-technologies/de2418b4-68d0-47be-a15e-e4ca51867191

> FDA 483 for Creation Technologies on February 14, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Creation Technologies
- Inspection Date: 2019-02-14
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of IEC Electronics Corp, a medical device contract manufacturer in Newark, NY, revealed significant deficiencies in their quality system. Observations included inadequate validation of manufacturing processes and software, insufficient control over nonconforming products, and failures in complaint handling procedures. These issues indicate a lack of robust quality management practices.

## Related Documents

- [WARNING_LETTER - 2020-03-05](https://www.keypedia.com/records/warning_letter/creation-technologies/5cd286bb-c886-4415-b2f4-587a3753e792)
- [483 - 2022-03-11](https://www.keypedia.com/records/483/creation-technologies/1324bca5-5f0e-420d-9c77-3113e408a566)

## Related Officers

- [Matthew D. Schnittker](https://www.keypedia.com/people/matthew-d-schnittker/cf76f07f-db6d-47a0-8412-7eb084d4fe8b)

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