FDA Inspection
Straumann USA LLCStraumann USA LLC – FDA Inspection, Jul 21, 2017
Record Details
This FDA Inspection record concerns Straumann USA LLC, with an inspection on July 21, 2017, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · f57f061c-13d5-4966-9105-ff7700d6a182
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1019048
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 1271.260(a)Contamination, mix ups, improper release
- 21 CFR 1271.265(c)(1)Release of HCT/Ps by responsible person
- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 806.10(b)Time to report - 10 days
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(e)Records of complaint investigation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Straumann USA LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 4, 2020 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| November 13, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 13, 2014 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Straumann USA LLC
- FDA Inspection 1122746 - 2020-03-04
- FDA Inspection 903595 - 2014-11-13
- FDA Inspection 903433 - 2014-11-13
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.