FDA Inspection
EBI Patient Care, Inc.EBI Patient Care, Inc. – FDA Inspection, Jan 17, 2018
Record Details
This FDA Inspection record concerns EBI Patient Care, Inc., with an inspection on January 17, 2018, issued by the Center for Devices and Radiological Health, covering devices.
- People
- Abby E. Pelletier (Issuing Officer)
- Laiza V. Garcia (Company Rep)
- Nydia E. Colon (Investigator)
View Company Profile
ID · 9c93a8f1-9d89-47b4-85ad-a9bf406bd4a7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1037799
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of EBI Patient Care, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 12, 2019 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 4, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for EBI Patient Care, Inc.
- FDA Inspection 1085738 - 2019-03-12
- FDA Inspection 921900 - 2015-02-04
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.