FDA Inspection
OSI ElectronicsOSI Electronics – FDA Inspection, May 24, 2012
Record Details
This FDA Inspection record concerns OSI Electronics, with an inspection on May 24, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- OSI Electronics
- Inspection Date
- May 24, 2012
- Product Type
- Devices
View Company Profile
ID · 2ad22545-df17-4303-a12d-b5f058e49716
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 783168
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.25(b)Training records
- 21 CFR 820.70(a)Production processes
- 21 CFR 820.90(a)Nonconforming product control
- 21 CFR 820.22Quality Audits - defined intervals
Full citation text and observation details available on the Dashboard.
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.