# FDA 483 - Please Me LLC - October 28, 2022

Source: https://www.keypedia.com/records/483/please-me-llc/ea72da00-5dc2-4a18-ab7f-32121a66ce42

> FDA 483 for Please Me LLC on October 28, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Please Me LLC
- Inspection Date: 2022-10-28
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Please Me LLC, a medical device manufacturer and initial importer in Brooklyn, NY, was cited for significant deficiencies in its quality system. The inspection revealed a complete absence of critical procedures for Medical Device Reporting (MDR), complaint handling, and corrective and preventive actions (CAPA). These findings indicate a fundamental lack of established processes for ensuring product quality and patient safety.

## Related Officers

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

Company: https://www.keypedia.com/companies/please-me-llc/3aff6759-6eea-4ca2-86a9-aafcf8cd3672

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