FDA Inspection
Teleflex LLC (NADC)FDA Inspection 1147635 - Teleflex LLC (NADC) - July 30, 2021
Record Details
This FDA Inspection record concerns Teleflex LLC (NADC), with an inspection on July 30, 2021, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Teleflex LLC (NADC)
- Inspection Date
- July 30, 2021
- Product Type
- Devices
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ID · 9bcf25f4-b0cb-4f1d-b1dc-3923181b2a66
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1147635
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.160(b)Distribution records
- 21 CFR 820.25(b)Training records
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of Teleflex LLC (NADC)
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 18, 2024 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 3, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 26, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Teleflex LLC (NADC)
- FDA Inspection 1235723 - 2024-03-18
- FDA Inspection 962796 - 2016-03-03
- FDA Inspection 885707 - 2014-06-26
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