Nuvasive, Inc.
Form 483 issued August 14, 2003 · San Diego, California
- Inspection
- Aug 13 – Aug 14, 2003
- Investigator
- E. Wilkerson-Bnnsko
- Observations
- 1
- Pages
- 1
- FEI number
- 3002980729
In short: On August 14, 2003, FDA issued a Form 483 with 1 observation to Nuvasive, Inc. in San Diego, California (FEI 3002980729) after an inspection that ran Aug 13 – Aug 14, 2003. The investigator was E. Wilkerson-Bnnsko. Most observations concern hCT/P; the most-cited regulation is 21 CFR 1271.55 (what records must accompany an HCT/P after the donor-eligibility determination is complete; and what records must I retain?).
At a glance
1 of 1 observations on this 483 concern hct/p.
Most cited: 21 CFR 1271.55 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The firm's summary of…
This inspection in context
E. Wilkerson-Bnnsko
1 document · 2003
Cites 1271.55 (what records must accompany an hct/p after the donor-eligibility determination is complete; and what records must i retain?) more than any other section. Most of their documents are for sites in California.
The firmNuvasive, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 1271.55
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Nuvasive, Inc.?
FDA listed 1 observation on this Form 483, mostly about hCT/P. The most-cited regulation is 21 CFR 1271.55 (what records must accompany an HCT/P after the donor-eligibility determination is complete; and what records must I retain?). The opening words of each observation are shown on this page.
Who inspected Nuvasive, Inc.?
E. Wilkerson-Bnnsko is named on this Form 483, for the inspection of Aug 13 – Aug 14, 2003. Each investigator has a profile showing what they cite most.
When was Nuvasive, Inc. inspected by FDA?
The inspection ran Aug 13 – Aug 14, 2003, and the Form 483 is dated August 14, 2003.
How do I get the full Form 483 for Nuvasive, Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.