FDA Inspection
Aea SrlAea Srl – FDA Inspection, Jun 15, 2017
Record Details
This FDA Inspection record concerns Aea Srl, with an inspection on June 15, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Lisa A. Stura (Issuing Officer)
View Company Profile
ID · 6c4d6d64-0a22-40cd-bc12-32c48b798d26
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1014903
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 1002.13Failure to submit
- 21 CFR 1002.10Failure to submit, distinct marking
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Aea Srl
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 10, 2020 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Aea Srl
- FDA Inspection 1116630 - 2020-01-10
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.