Integra LifeSciences Corporation
FDA inspection history across 3 sites, 2011 to 2023
- 2
- Warning letters
- 2
- Form 483s
Every document, by year
- Warning letter
- Form 483
2011: one warning letter and one Form 483; 2012: one Form 483; 2023: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2011–12Two Form 483s and one warning letter, at Plainsboro, New Jersey and Plainsbo ro, New Jersey.
- 2011The longest 483 on file: 8 observations over 9 pages at Plainsbo ro, New Jersey.
- 2023One warning letter, at Princeton, New Jersey.
Cited most
Across all Integra LifeSciences observations on file
- 21 CFR 820.70(c)Production and process controls5
- 21 CFR 820.100(a)Corrective and preventive action2
- 21 CFR 820.90(a)Nonconforming product2
- 21 CFR 803.50(a)(2)If I am a manufacturer, what reporting requirements apply to me?1
- 21 CFR 803.56If I am a manufacturer, in what circumstances must I submit a supplemental or followup report and what are the requirements for such reports?1
The complete Integra LifeSciences file.
All 4 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Plainsboro, New Jersey
One Form 483 and one warning letter · 2011 to 2012 · 7 observations
Latest: Form 483, Jul 30, 2012 →Princeton, New Jersey
One warning letter · 2023
Latest: Warning letter, Jul 17, 2023 →Plainsbo ro, New Jersey
One Form 483 · 2011 · 8 observations
Latest: Form 483, Aug 25, 2011 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-07-17 | Warning letter Warning letter | Princeton, New Jersey | — | $99 |
| 2012-07-30 | 483 Form 483 | Plainsboro, New Jersey | 7 | $99 |
| 2011-12-21 | Warning letter Warning letter | Plainsboro, New Jersey | — | $99 |
| 2011-08-25 | 483 Form 483 | Plainsbo ro, New Jersey | 8 | $99 |
Investigators on these documents
Loretta Nemchik (2)Meredith L. Sheridan (2)Barbara J. Wilimczyk-Macri (1)
FEI number 1121308 · most recent document Jul 17, 2023
About Integra LifeSciences Corporation
How many FDA Form 483s has Integra LifeSciences Corporation received?
FDA Intel has 2 Form 483s on file for Integra LifeSciences Corporation; the most recent is dated Jul 30, 2012.
When was Integra LifeSciences Corporation last inspected by FDA?
The most recent FDA inspection document on file for Integra LifeSciences Corporation is a Form 483 dated Jul 30, 2012, for the site in Plainsboro, New Jersey.
What did FDA cite at Integra LifeSciences Corporation?
The regulations cited most in the observations on file for Integra LifeSciences Corporation are 21 CFR 820.70(c) (Production and process controls), 5 times; 21 CFR 820.100(a) (Corrective and preventive action), 2 times; 21 CFR 820.90(a) (Nonconforming product), 2 times.
Has Integra LifeSciences Corporation received an FDA warning letter?
Yes. FDA Intel has 2 FDA warning letters on file for Integra LifeSciences Corporation; the most recent is dated Jul 17, 2023.