FDA Inspection
21st Century Scientific Inc21st Century Scientific Inc – FDA Inspection, Mar 21, 2017
Record Details
This FDA Inspection record concerns 21st Century Scientific Inc, with an inspection on March 21, 2017, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · 97858bc4-00a6-48e3-8f9e-1dba39000281
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1007072
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.250(b)Sampling plans
- 21 CFR 820.50(a)(1)Documented evaluation
- 21 CFR 820.50(b)Supplier notification of changes
- 21 CFR 820.72(a)Equipment control activity documentation
- 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 21st Century Scientific Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| September 17, 2021 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 12, 2018 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| July 13, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 29, 2008 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for 21st Century Scientific Inc
- FDA Inspection 1151898 - 2021-09-17
- FDA Inspection 1066564 - 2018-09-12
- FDA Inspection 736167 - 2011-07-13
- FDA Inspection 547939 - 2008-10-29
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.