FDA Inspection
CytoTherm L.P.CytoTherm L.P. – FDA Inspection, Oct 27, 2016
Record Details
This FDA Inspection record concerns CytoTherm L.P., with an inspection on October 27, 2016, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · f4a52aa2-64f1-42d5-bc82-6cf66adbf900
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 991419
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.184DHR content
- 21 CFR 820.25(b)Training records
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.40Procedures not adequately established or maintained
- 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 CytoTherm L.P.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| November 14, 2019 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 31, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 9, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for CytoTherm L.P.
- FDA Inspection 1123811 - 2019-11-14
- FDA Inspection 873309 - 2014-03-31
- FDA Inspection 713076 - 2011-03-09
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.