# FDA 483 - Polymerex Medical Corp - September 23, 2019

Source: https://www.keypedia.com/records/483/polymerex-medical-corp/04363a40-bc6c-4009-b9c6-88f3c7520e02

> FDA 483 for Polymerex Medical Corp on September 23, 2019. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Polymerex Medical Corp
- Inspection Date: 2019-09-23
- Product Type: other
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Polymerex Medical Corp in San Diego, CA, a medical device manufacturer, identified one significant observation. The firm was cited for failing to adequately establish process control procedures. Specifically, an employee was observed using incorrect swaging pressure during manufacturing, which was also linked to multiple non-conformance reports.

## Related Officers

- [Jenny L Mccardell](https://www.keypedia.com/people/jenny-l-mccardell/b8fa04db-6acc-48d1-b0be-56777704ae51)

Company: https://www.keypedia.com/companies/polymerex-medical-corp/1fcd36e5-83b0-4ae5-9608-ed0fafec0d66

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