Integra LifeSciences Corporation
Form 483 issued August 25, 2011 · Plainsbo ro, New Jersey
- Inspection
- Jul 22 – Aug 25, 2011
- Investigators
- Loretta Nemchik· Meredith L. Sheridan
- Observations
- 8
- Pages
- 9
- FEI number
- 1121308
In short: On August 25, 2011, FDA issued a Form 483 with 8 observations to Integra LifeSciences Corporation in Plainsbo ro, New Jersey (FEI 1121308) after an inspection that ran Jul 22 – Aug 25, 2011. The investigators were Loretta Nemchik and Meredith L. Sheridan. Most observations concern production & process controls and cAPA; the most-cited regulation is 21 CFR 820.70 (production and process controls).
At a glance
Production & process controls and capa account for 8 of 8 observations.
What FDA observed
Preview: the opening words of each observation- 01
Buildings are not of suitable design…
- 02
Observation 2: scanned text, readable in the full document.
- 03
Procedures to control environmental conditions have not been adequately established. A. Your environmental control procedures as…
- 04
Procedures that define the responsibility for review and the authority for the disposition of nonconforming product…
This inspection in context
Loretta Nemchik
3 documents · 2002–2012
Cites 820.70(c) (production and process controls) more than any other section. Most of their documents are for sites in New Jersey.
The firmIntegra LifeSciences Corporation history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.70(f)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Integra LifeSciences Corporation?
FDA listed 8 observations on this Form 483, mostly about production & process controls and cAPA. The most-cited regulation is 21 CFR 820.70 (production and process controls). The opening words of each observation are shown on this page.
Who inspected Integra LifeSciences Corporation?
Loretta Nemchik and Meredith L. Sheridan are named on this Form 483, for the inspection of Jul 22 – Aug 25, 2011. Each investigator has a profile showing what they cite most.
When was Integra LifeSciences Corporation inspected by FDA?
The inspection ran Jul 22 – Aug 25, 2011, and the Form 483 is dated August 25, 2011.
How do I get the full Form 483 for Integra LifeSciences Corporation?
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.