# FDA 483 - Paragon Manufacturing Corp. - September 11, 2019

Source: https://www.globalkeysolutions.net/records/483/paragon-manufacturing-corp/947590db-d96e-4bef-a09f-6d5f287ad65a

> FDA 483 for Paragon Manufacturing Corp. on September 11, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Paragon Manufacturing Corp.
- Inspection Date: 2019-09-11
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: Paragon Manufacturing Corp., a contract manufacturer in Everett, WA, was cited for multiple quality system deficiencies during an FDA inspection. The firm failed to adequately establish and implement procedures for incoming product acceptance, control of nonconforming product, corrective and preventive actions, equipment calibration, supplier agreements, purchased product conformity, and document control. These issues indicate significant gaps in the firm's quality management system.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/paragon-manufacturing-corp/688d51ab-4461-4ec7-940f-c18126977d75

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-vi/6e5a2a08-f464-4979-a759-7b0383370822