# FDA 483 - Whele LLC DBA Perch - June 06, 2022

Source: https://www.keypedia.com/records/483/whele-llc-dba-perch/1ba2e354-eafe-4d77-916a-061a033fc6f3

> FDA 483 for Whele LLC DBA Perch on June 06, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Whele LLC DBA Perch
- Inspection Date: 2022-06-06
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: Whele LLC DBA Perch, an initial importer of medical devices, was cited for significant deficiencies in its quality system during an FDA inspection. The firm failed to adequately establish and implement procedures for complaint handling, Medical Device Reporting (MDR), supplier quality, sampling plans, personnel training, corrective and preventive actions (CAPA), and document control. These issues led to uninvestigated complaints, unreported adverse events, and a lack of control over critical quality processes for products like the Mighty Bliss Electric Heating Pad and CareTouch monitoring systems.

## Related Documents

- [483 - 2023-07-18](https://www.keypedia.com/records/483/whele-llc-dba-perch/771f1074-633c-4abf-ada3-2fa3b583f750)

## Related Officers

- [Sunita Pandey](https://www.keypedia.com/people/sunita-pandey/008e5bb8-0eb3-45d8-8524-734ac0454250)
- [Sara M. Onyango](https://www.keypedia.com/people/sara-m-onyango/643c6ad3-9747-4bc2-9e8e-72f97b11e659)

Company: https://www.keypedia.com/companies/whele-llc-dba-perch/114a5f37-7375-4993-a6e2-7d5fb921e537

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94