FDA Inspection
Nurse Assist, LLCNurse Assist, LLC – FDA Inspection, Jun 29, 2011
Record Details
This FDA Inspection record concerns Nurse Assist, LLC, with an inspection on June 29, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Nurse Assist, LLC
- Inspection Date
- June 29, 2011
- Product Type
- Devices
View Company Profile
ID · 921b918a-eb48-4334-9cfe-3472eab5d7a8
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 732989
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.22Quality audits - auditor independence
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.184DHR content
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Nurse Assist, LLC
6| Date | Classification | Office | Project area |
|---|---|---|---|
| September 21, 2023 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 9, 2020 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 25, 2018 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 23, 2016 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 16, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Nurse Assist, LLC
- FDA Inspection 1219092 - 2023-09-21
- FDA Inspection 1122288 - 2020-03-09
- FDA Inspection 1069748 - 2018-10-25
- FDA Inspection 994514 - 2016-11-23
- FDA Inspection 777628 - 2012-04-16
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