# FDA 483 - Primrose Medical Inc. - October 26, 2022

Source: https://www.keypedia.com/records/483/primrose-medical-inc/cec13cee-79b3-4359-8469-18475fb617f5

> FDA 483 for Primrose Medical Inc. on October 26, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Primrose Medical Inc.
- Inspection Date: 2022-10-26
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: Primrose Medical Inc., a manufacturer of Class II medical devices in East Walpole, MA, received 11 observations during an FDA inspection. The observations primarily highlight significant deficiencies in the firm's quality system, particularly concerning design controls, risk analysis, CAPA procedures, complaint handling, supplier controls, personnel training, and internal audits. These issues indicate a broad lack of adherence to regulatory requirements for medical device manufacturing.

## Related Officers

- [Sunita Pandey](https://www.keypedia.com/people/sunita-pandey/008e5bb8-0eb3-45d8-8524-734ac0454250)

Company: https://www.keypedia.com/companies/primrose-medical-inc/183a9d6e-b369-4fad-9cf6-a3f528b076a3

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