Elite Laboratories Inc
Form 483 issued February 2, 2016 · Northvale, New Jersey
- Inspection
- Jan 5 – Feb 2, 2016
- Investigators
- Jose M. Cayuela· Liatte Krueger· Melissa T. Roy
- Observations
- 9
- Pages
- 12
- FEI number
- 3002644678
In short: On February 2, 2016, FDA issued a Form 483 with 9 observations to Elite Laboratories Inc in Northvale, New Jersey (FEI 3002644678) after an inspection that ran Jan 5 – Feb 2, 2016. The investigators were Jose M. Cayuela, Liatte Krueger, Melissa T. Roy and Nancy F. Scheraga. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 314.80 (postmarketing reporting of adverse drug experiences).
At a glance
Quality system and laboratory controls account for 6 of 9 observations.
Most cited: 21 CFR 314.80 (3×) · 211.165 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Determinations of conformance to appropriate written specifications for acceptance are…
- 03
The accuracy , sensitivity , specificity and reproducibility if test methods hiive not…
- 04
Deviations from written test procedures…
This inspection in context
Jose M. Cayuela
23 documents · 2012–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmElite Laboratories Inc history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 314.80
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Elite Laboratories Inc?
FDA listed 9 observations on this Form 483, mostly about quality system and laboratory controls. The most-cited regulation is 21 CFR 314.80 (postmarketing reporting of adverse drug experiences). The opening words of each observation are shown on this page.
Who inspected Elite Laboratories Inc?
Jose M. Cayuela, Liatte Krueger, Melissa T. Roy and Nancy F. Scheraga are named on this Form 483, for the inspection of Jan 5 – Feb 2, 2016. Each investigator has a profile showing what they cite most.
When was Elite Laboratories Inc inspected by FDA?
The inspection ran Jan 5 – Feb 2, 2016, and the Form 483 is dated February 2, 2016.
How do I get the full Form 483 for Elite Laboratories 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.