FDA Inspection
Spring Health Products IncSpring Health Products Inc – FDA Inspection, Aug 17, 2012
Record Details
This FDA Inspection record concerns Spring Health Products Inc, with an inspection on August 17, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Spring Health Products Inc
- Inspection Date
- August 17, 2012
- Product Type
- Devices
View Company Profile
ID · c7d57ec1-31aa-4f0c-9b7c-62918f9a6165
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 796941
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.100(b)Documentation
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 820.30(j)Design history file
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Spring Health Products Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 22, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 18, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 22, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Spring Health Products Inc
- FDA Inspection 1165998 - 2022-03-22
- FDA Inspection 1074846 - 2018-12-18
- FDA Inspection 931033 - 2015-06-22
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.