FDA Inspection
Welch Allyn Inc (Baxter affiliate)Welch Allyn Inc (Baxter affiliate) – FDA Inspection, May 10, 2011
Record Details
This FDA Inspection record concerns Welch Allyn Inc (Baxter affiliate), with an inspection on May 10, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- May 10, 2011
- Product Type
- Devices
View Company Profile
ID · f4f278d1-9316-4151-94d2-85b5632f37c1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 723748
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
7- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.198(b)Review and evaluation for investigation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 820.200(d)Service reports
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Other FDA inspections of Welch Allyn Inc (Baxter affiliate)
3| Date | Classification | Office | Project area |
|---|---|---|---|
| July 15, 2022 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 7, 2017 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 18, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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