FDA Inspection
Industrie Borla SpaIndustrie Borla Spa – FDA Inspection, Mar 28, 2018
Record Details
This FDA Inspection record concerns Industrie Borla Spa, with an inspection on March 28, 2018, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
View Company Profile
ID · e0796bf6-d453-4cd9-a48a-6330c5b09e1b
Inspection Facts
- Inspection number
- 1046510
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
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.