# FDA 483 - Beverly Hills Uniforms - October 26, 2021

Source: https://www.keypedia.com/records/483/beverly-hills-uniforms/316c1f18-8e9c-4d13-8b71-8660d8f108b8

> FDA 483 for Beverly Hills Uniforms on October 26, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Beverly Hills Uniforms
- Inspection Date: 2021-10-26
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Beverly Hills Uniforms, a medical device manufacturer in Bronx, NY, was cited with a Form FDA-483 following an inspection. The inspection revealed significant deficiencies in the firm's quality system, including the absence of written procedures for Medical Device Reporting, complaint handling, and corrective and preventive actions. Additionally, the firm failed to ensure proper device traceability through control numbers, lot numbers, and Unique Device Identifiers.

## Related Officers

- [investigator](https://www.keypedia.com/people/kwong-p-lee/f4778925-1fad-4988-9e39-86482896c4fa)

Company: https://www.keypedia.com/companies/beverly-hills-uniforms/791c7967-6331-4a3e-9884-bd19cd398490

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