FDA Inspection
Robin Industries Healthcare DivisionRobin Industries Healthcare Division – FDA Inspection, Aug 25, 2016
Record Details
This FDA Inspection record concerns Robin Industries Healthcare Division, with an inspection on August 25, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- August 25, 2016
- Product Type
- Devices
View Company Profile
ID · 5106fa00-811b-4549-971d-56223cf8481b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 984251
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.70(a)Production processes
- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Robin Industries Healthcare Division
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 26, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 30, 2021 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Robin Industries Healthcare Division
- FDA Inspection 1219662 - 2023-09-26
- FDA Inspection 1151713 - 2021-08-30
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.