Nuvasive, Inc.

FDA inspection history in San Diego, California, 2003 to 2013

1
Warning letter
1
Form 483

Every document, by year

  • Warning letter
  • Form 483

2003: one Form 483; 2013: one warning letter.

The story so far

Built from the dates and citations on the documents themselves.

  1. 2003One Form 483, at San Diego, California.
  2. 2013One warning letter, at San Diego, California.

Cited most

Across all Nuvasive observations on file

  • 21 CFR 1271.55
    What records must accompany an HCT/P after the donor-eligibility determination is complete; and what records must I retain?
    1

The complete Nuvasive file.

All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.

$198

The price of the documents, added to your cart together

Sites

Documents

2 on file, newest first
DateDocumentPrice
2013-03-12Warning letter Warning letter$99
2003-08-14483 Form 483$99

Investigators on these documents

E. Wilkerson-Bnnsko (1)

FEI number 3002980729 · most recent document Mar 12, 2013

About Nuvasive, Inc.

How many FDA Form 483s has Nuvasive, Inc. received?

FDA Intel has 1 Form 483 on file for Nuvasive, Inc.; the most recent is dated Aug 14, 2003.

When was Nuvasive, Inc. last inspected by FDA?

The most recent FDA inspection document on file for Nuvasive, Inc. is a Form 483 dated Aug 14, 2003, for the site in San Diego, California.

What did FDA cite at Nuvasive, Inc.?

The regulations cited most in the observations on file for Nuvasive, Inc. are 21 CFR 1271.55 (What records must accompany an HCT/P after the donor-eligibility determination is complete; and what records must I retain?), 1 time.

Has Nuvasive, Inc. received an FDA warning letter?

Yes. FDA Intel has 1 FDA warning letter on file for Nuvasive, Inc.; the most recent is dated Mar 12, 2013.