FDA Inspection
TELEFLEX LLCTELEFLEX LLC – FDA Inspection, Aug 26, 2022
Record Details
This FDA Inspection record concerns TELEFLEX LLC, with an inspection on August 26, 2022, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- TELEFLEX LLC
- Inspection Date
- August 26, 2022
- Product Type
- Devices
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ID · ebb84031-3a05-49ab-8263-aeaf82e1ee08
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1179604
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.100(b)Documentation
- 21 CFR 820.30(h)Design transfer - Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of TELEFLEX LLC
7| Date | Classification | Office | Project area |
|---|---|---|---|
| September 2, 2021 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 28, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 22, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 22, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 11, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for TELEFLEX LLC
- FDA Inspection 1156198 - 2021-09-02
- FDA Inspection 892743 - 2014-08-28
- FDA Inspection 897373 - 2014-08-22
- FDA Inspection 897366 - 2014-08-22
- FDA Inspection 842225 - 2013-01-11
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