FDA Inspection
Phillips-Medisize Costa Mesa, LLCPhillips-Medisize Costa Mesa, LLC – FDA Inspection, Mar 15, 2018
Record Details
This FDA Inspection record concerns Phillips-Medisize Costa Mesa, LLC, with an inspection on March 15, 2018, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · 94ab23ba-5631-478b-a7e0-cb56ab6a295b
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1044809
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.50(a)(2)Supplier oversight
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Phillips-Medisize Costa Mesa, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 11, 2021 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 3, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Phillips-Medisize Costa Mesa, LLC
- FDA Inspection 1139659 - 2021-03-11
- FDA Inspection 916748 - 2015-03-03
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.