Renaissance Lakewood, LLC
Form 483 issued March 15, 2018 · Lakewood, New Jersey
- Inspection
- Feb 22 – Mar 15, 2018
- Investigators
- Emmanuel J. Ramos· Nicholas Violand
- Observations
- 1
- Pages
- 4
- FEI number
- 2240829
In short: On March 15, 2018, FDA issued a Form 483 with 1 observation to Renaissance Lakewood, LLC in Lakewood, New Jersey (FEI 2240829) after an inspection that ran Feb 22 – Mar 15, 2018. The investigators were Emmanuel J. Ramos and Nicholas Violand. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.165 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The accuracy, sensitivity and reproducibility of test methods have not been established…
This inspection in context
Emmanuel J. Ramos
9 documents · 2017–2021
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in New Jersey.
The firmRenaissance Lakewood, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.165
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Renaissance Lakewood, LLC?
FDA listed 1 observation on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected Renaissance Lakewood, LLC?
Emmanuel J. Ramos and Nicholas Violand are named on this Form 483, for the inspection of Feb 22 – Mar 15, 2018. Each investigator has a profile showing what they cite most.
When was Renaissance Lakewood, LLC inspected by FDA?
The inspection ran Feb 22 – Mar 15, 2018, and the Form 483 is dated March 15, 2018.
How do I get the full Form 483 for Renaissance Lakewood, LLC?
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.