# FDA 483 - TELEFLEX LLC - August 26, 2022

Source: https://www.keypedia.com/records/483/teleflex-llc/40d76031-a0d2-48d6-a1ef-8d7e175762f0

> FDA 483 for TELEFLEX LLC on August 26, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: TELEFLEX LLC
- Inspection Date: 2022-08-26
- Product Type: device
- Office Name: Atlanta District Office
- Summary: TELEFLEX LLC, a medical device specification developer in Morrisville, NC, was cited for significant deficiencies in its quality system during an FDA inspection. The firm failed to adequately document corrective and preventive actions, including addressing root causes and monitoring effectiveness for various medical devices. Additionally, procedures for design transfer and control of nonconforming products were found to be insufficient, leading to product issues and unreliable reconciliation of recalled devices.

## Related Officers

- [Adaliz Santaliz-Cruz](https://www.keypedia.com/people/adaliz-santaliz-cruz/47bd4220-e6cc-4582-a4f5-bd4337f92622)
- [Gamal A. Norton](https://www.keypedia.com/people/gamal-a-norton/6b52c9e6-d579-4994-81ee-e734eb1f0a67)
- [issuing_officer](https://www.keypedia.com/people/mary-l-schuckmann/fdbfffff-ef4b-49a2-8ea3-6254a600aaac)

Company: https://www.keypedia.com/companies/teleflex-llc/3c94ef7c-2d6f-44d3-9b84-42919643c603

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