FDA Inspection
Sharp U.K. Manufacturing (SUKM)Sharp U.K. Manufacturing (SUKM) – FDA Inspection, Apr 23, 2018
Record Details
This FDA Inspection record concerns Sharp U.K. Manufacturing (SUKM), with an inspection on April 23, 2018, issued by the Center for Devices and Radiological Health, covering devices.
- People
- Gregory M. Bessette (Issuing Officer)
- Michael P. Sweeney (Issuing Officer)
View Company Profile
ID · f48a759b-563c-44e8-80b1-4f073238a18c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1050399
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 1010.2(c)Certification not based on adequate test/testing program
- 21 CFR 1030.10(c)(3)(iv)Door position
- 21 CFR 1030.10(c)(3)(i)tests--errors and uncertainties accounted for
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Sharp U.K. Manufacturing (SUKM)
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 3, 2016 | OAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
Other documents for Sharp U.K. Manufacturing (SUKM)
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.