# FDA 483 - WIDE USA CORPORATION - November 27, 2019

Source: https://www.globalkeysolutions.net/records/483/wide-usa-corporation/0427dfda-ad06-498c-ba9b-a2dd7bee041b

> FDA 483 for WIDE USA CORPORATION on November 27, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: WIDE USA CORPORATION
- Inspection Date: 2019-11-27
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of WON USA CORPORATION in Anaheim, CA, an initial importer, revealed significant deficiencies in its quality system. The firm failed to adequately establish procedures for evaluating complaints to determine if Medical Device Reporting was required. Additionally, the company lacked established written procedures for document control, including approval, distribution, and changes.

## Related Officers

- [Angelica G Aziz](https://www.globalkeysolutions.net/people/angelica-g-aziz/3aea89c9-72d6-4865-984e-936dd61d2786)

Company: https://www.globalkeysolutions.net/companies/wide-usa-corporation/6b53daca-fd7c-4a30-a8fb-fcfc0c68fd10

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6