FDA Inspection
Eagle Health SuppliesEagle Health Supplies – FDA Inspection, Jul 26, 2010
Record Details
This FDA Inspection record concerns Eagle Health Supplies, with an inspection on July 26, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Eagle Health Supplies
- Inspection Date
- July 26, 2010
- Product Type
- Devices
View Company Profile
ID · be256001-e7b1-47e2-bc25-97cb21cdb5d9
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 674218
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
12- 21 CFR 820.80(b)Incoming acceptance records, documentation
- 21 CFR 820.20(d)Quality plan
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
Showing 10 of 12 citations.
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Eagle Health Supplies
2| Date | Classification | Office | Project area |
|---|---|---|---|
| June 1, 2016 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| May 11, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Eagle Health Supplies
- FDA Inspection 998128 - 2016-06-01
- FDA Inspection 781134 - 2012-05-11
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.