FDA Inspection
TELEFLEX LLCTELEFLEX LLC – FDA Inspection, Mar 23, 2010
Record Details
This FDA Inspection record concerns TELEFLEX LLC, with an inspection on March 23, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- TELEFLEX LLC
- Inspection Date
- March 23, 2010
- Product Type
- Devices
View Company Profile
ID · 6c5566f0-11a9-44ed-b5e4-8c0361502b36
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 662100
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
7- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)(2)Investigation
- 21 CFR 820.100(a)(3)Identification of actions needed
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.90(b)(2)Product rework documentation, DHR {see also 820.184}
- 21 CFR 820.184DHR content
Full citation text and observation details available on the Dashboard.
Other FDA inspections of TELEFLEX LLC
7| Date | Classification | Office | Project area |
|---|---|---|---|
| August 26, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| 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 |
Other documents for TELEFLEX LLC
- FDA Inspection 1179604 - 2022-08-26
- FDA Inspection 1156198 - 2021-09-02
- FDA Inspection 892743 - 2014-08-28
- FDA Inspection 897373 - 2014-08-22
- FDA Inspection 897366 - 2014-08-22
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