# FDA 483 - Omega Plastics Inc. - July 16, 2018

Source: https://www.globalkeysolutions.net/records/483/omega-plastics-inc/55d048f9-93f6-4663-83ab-fd7a0777fb74

> FDA 483 for Omega Plastics Inc. on July 16, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Omega Plastics Inc.
- Inspection Date: 2018-07-16
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: Omega Plastics, Inc. in Clinton Township, MI, received a Form FDA 483 with six observations related to significant deficiencies in their quality system for medical device manufacturing. The inspection revealed issues with process validation, process controls, environmental controls in cleanrooms, corrective and preventive actions, quality audits, and control of nonconforming product. These findings indicate a need for comprehensive improvements across multiple critical manufacturing and quality assurance areas.

## Related Officers

- [Medical Device Senior Operations Officer at FDA](https://www.globalkeysolutions.net/people/thomas-a-peter/48a36892-cc03-42bb-8960-978d18f2147a)
- [Regulatory Counsel, CDER Compliance, Office of Manufacturing Quality](https://www.globalkeysolutions.net/people/emilie-e-kahn/fac179e5-478f-4e75-9632-40d921f44a8f)

Company: https://www.globalkeysolutions.net/companies/omega-plastics-inc/04f054b5-de9e-4e1c-a1c5-00c3b2ff7d4b

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0