# FDA 483 - Wykle, Inc. - May 10, 2019

Source: https://www.globalkeysolutions.net/records/483/wykle-inc/8106515b-0c1b-49ea-a9c0-2000f9276a10

> FDA 483 for Wykle, Inc. on May 10, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Wykle, Inc.
- Inspection Date: 2019-05-10
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: Wykle, Inc. in Carson City, NV, a manufacturer of Class 2 amalgam alloy, received an FDA Form 483 with eight observations during an inspection from May 6-10, 2019. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate procedures for complaint handling, equipment calibration, process validation, nonconforming product control, document control, quality audits, management review, and design change. These issues indicate a systemic lack of established and implemented quality management procedures.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/paul-m-kawamoto/0a24b110-12de-4736-8d98-7a023ceec01e)

Company: https://www.globalkeysolutions.net/companies/wykle-inc/f6ee1bfe-7623-4861-a259-0341e0f1412d

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b