Integra LifeSciences Corporation
Form 483 issued July 30, 2012 · Plainsboro, New Jersey
- Inspection
- Jun 12 – Jul 30, 2012
- Investigators
- Barbara J. Wilimczyk-Macri· Loretta Nemchik· Meredith L. Sheridan
- Observations
- 7
- Pages
- 11
- FEI number
- 1121308
In short: On July 30, 2012, FDA issued a Form 483 with 7 observations to Integra LifeSciences Corporation in Plainsboro, New Jersey (FEI 1121308) after an inspection that ran Jun 12 – Jul 30, 2012. The investigators were Barbara J. Wilimczyk-Macri, Loretta Nemchik and Meredith L. Sheridan. Most observations concern cAPA and production & process controls; the most-cited regulation is 21 CFR 820.70 (production and process controls).
At a glance
CAPA and production & process controls account for 6 of 7 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for corrective and preventive action have…
- 02
Products that do not conform to specifications…
- 03
Procedures to control environmental conditions have not been established. Your firm failed to provide Alert/Action Notification…
- 04
Software used as part of the quality system has not been adequately validated for its intended…
This inspection in context
Barbara J. Wilimczyk-Macri
5 documents · 2012–2016
Cites 211.42 (design and construction features) 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 820.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Integra LifeSciences Corporation?
FDA listed 7 observations on this Form 483, mostly about cAPA, production & process controls and records & documents. 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?
Barbara J. Wilimczyk-Macri, Loretta Nemchik and Meredith L. Sheridan are named on this Form 483, for the inspection of Jun 12 – Jul 30, 2012. Each investigator has a profile showing what they cite most.
When was Integra LifeSciences Corporation inspected by FDA?
The inspection ran Jun 12 – Jul 30, 2012, and the Form 483 is dated July 30, 2012.
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.