# FDA 483 - Robling Medical Inc - November 26, 2019

Source: https://www.keypedia.com/records/483/robling-medical-inc/493e15c8-6540-4cb0-9fdc-f412e7998627

> FDA 483 for Robling Medical Inc on November 26, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Robling Medical Inc
- Inspection Date: 2019-11-26
- Product Type: device
- Office Name: Atlanta District Office
- Summary: Robling Medical Inc, a contract manufacturer in Youngsville, NC, was cited for five observations during an FDA inspection. The inspection revealed significant deficiencies in environmental control procedures, corrective and preventive action documentation, statistical techniques for product acceptability, rework documentation, and complaint file maintenance. These issues indicate a lack of adherence to quality system requirements.

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## Related Officers

- [issuing_officer](https://www.keypedia.com/people/david-e-lowe/1a2492c2-4a81-4486-b3af-37f6b7b5216a)

Company: https://www.keypedia.com/companies/robling-medical-inc/98ba95cf-1a99-4ac9-adc4-d87193511cd9

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