# FDA 483 - Acme United Corporation - March 13, 2020

Source: https://www.keypedia.com/records/483/acme-united-corporation/1bf070a1-f774-4f0e-ba55-5bd04c664561

> FDA 483 for Acme United Corporation on March 13, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Acme United Corporation
- Inspection Date: 2020-03-13
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: Acme United Corporation, a repacker/relabeler of first aid convenience kits and Class II CPR masks in Vancouver, WA, was inspected by the FDA. The inspection revealed multiple deficiencies in their quality system, including inadequate procedures for complaint handling, control of nonconforming product, equipment calibration, device history records, and purchasing controls. These issues indicate a systemic failure to adequately establish and implement required quality procedures.

## Related Officers

- [investigator](https://www.keypedia.com/people/christopher-s-genther/e71df42c-9adf-4a78-93e5-c364dcc06b35)
- [Investigator](https://www.keypedia.com/people/alexandria-l-capuano/f76c710a-613f-42b2-8958-1292fa329112)

Company: https://www.keypedia.com/companies/acme-united-corporation/f719cc33-de99-46c4-b10a-166da1062a14

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