# FDA 483 - Encision Inc. - September 20, 2019

Source: https://www.globalkeysolutions.net/records/483/encision-inc/ec3db832-6a91-48f3-8e4e-c7cdae1df428

> FDA 483 for Encision Inc. on September 20, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Encision Inc.
- Inspection Date: 2019-09-20
- Product Type: device
- Office Name: Denver District Office
- Summary: Encision Inc., a medical device manufacturer in Boulder, CO, received an FDA Form 483 citing significant deficiencies in its quality system. Observations included inadequate control over non-conforming product, insufficient procedures for corrective and preventive actions, and failures in establishing and adhering to complaint handling processes. These issues collectively indicate a need for improved procedural controls and compliance.

## Related Officers

- [Tuan A Nguyen](https://www.globalkeysolutions.net/people/tuan-a-nguyen/50723bbb-29a1-4e7a-a5aa-123ec3866065)
- [investigator](https://www.globalkeysolutions.net/people/matthew-m-vernon/f77e8c18-8614-49e3-9b19-3327b7fe7648)

Company: https://www.globalkeysolutions.net/companies/encision-inc/fa84ff9e-c141-4cb9-8cb3-f8a95908068b

Office: https://www.globalkeysolutions.net/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face