# FDA 483 - Defender Safety, Inc - October 05, 2022

Source: https://www.keypedia.com/records/483/defender-safety-inc/09c47461-c0ac-4f29-a16f-9c9992c8a2e7

> FDA 483 for Defender Safety, Inc on October 05, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Defender Safety, Inc
- Inspection Date: 2022-10-05
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Defender Safety, Inc. in Plainview, NY, a repackager and design specification developer of Class II medical devices (PPEs), identified three significant observations. The firm failed to establish written agreements with suppliers for change notifications, particularly for medical grade masks. Additionally, procedures for acceptance activities were inadequate, lacking evidence of required testing for bacterial and particulate filtration efficiency, and no quality audits had been performed by the firm.

## Related Officers

- [Jacqueline S. Warner](https://www.keypedia.com/people/jacqueline-s-warner/d001f4ec-db46-4d78-a5dd-efea7ddfb893)

Company: https://www.keypedia.com/companies/defender-safety-inc/3bafa721-2e0a-4016-94c6-bd60c87b1c12

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961