# FDA 483 - Greer Laboratories, Inc. - November 01, 2022

Source: https://www.keypedia.com/records/483/greer-laboratories-inc/da97924d-acd1-4dcb-b277-e9f0c1afd03c

> FDA 483 for Greer Laboratories, Inc. on November 01, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Greer Laboratories, Inc.
- Inspection Date: 2022-11-01
- Product Type: device
- Office Name: Atlanta District Office
- Summary: Greer Laboratories, Inc. in Lenoir, NC, was inspected and cited for significant deficiencies in its quality system for medical devices. Observations included a lack of design validation for medical devices, failure to timely report a recall, and inadequate procedures and documentation for corrective and preventive actions, quality audits, supplier qualification, and management reviews. These issues indicate systemic problems in maintaining a compliant quality management system.

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## Related Officers

- [Christopher B. May](https://www.keypedia.com/people/christopher-b-may/b2173a59-d37b-41f1-aa39-eefd854722b8)

Company: https://www.keypedia.com/companies/greer-laboratories-inc/9e93bfa2-3578-44bb-93cd-fa80496d73a5

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7