Raritan Pharmaceuticals, Inc
Form 483 issued April 14, 2016 · East Brunswick, New Jersey
- Inspection
- Apr 7 – Apr 14, 2016
- Investigator
- Frederick Razzaghi
- Observations
- 1
- Pages
- 1
- FEI number
- 3004083931
In short: On April 14, 2016, FDA issued a Form 483 with 1 observation to Raritan Pharmaceuticals, Inc in East Brunswick, New Jersey (FEI 3004083931) after an inspection that ran Apr 7 – Apr 14, 2016. The investigator was Frederick Razzaghi. Most observations concern quality system; the most-cited regulation is 21 CFR 211.198 (complaint files).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.198 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Complaint records are deficient in that they do not include complete records of investigations: a. Investigations…
This inspection in context
Frederick Razzaghi
15 documents · 2014–2024
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New Jersey.
The firmRaritan Pharmaceuticals, 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 211.198
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Raritan Pharmaceuticals, Inc?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.198 (complaint files). The opening words of each observation are shown on this page.
Who inspected Raritan Pharmaceuticals, Inc?
Frederick Razzaghi is named on this Form 483, for the inspection of Apr 7 – Apr 14, 2016. Each investigator has a profile showing what they cite most.
When was Raritan Pharmaceuticals, Inc inspected by FDA?
The inspection ran Apr 7 – Apr 14, 2016, and the Form 483 is dated April 14, 2016.
How do I get the full Form 483 for Raritan Pharmaceuticals, 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.