Raritan Pharmaceuticals, Inc
Form 483 issued January 8, 2018 · East Brunswick, New Jersey
- Inspection
- Dec 5, 2017 – Jan 8, 2018
- Investigator
- Guerlain Ulysse
- Observations
- 5
- Pages
- 6
- FEI number
- 3004083931
In short: On January 8, 2018, FDA issued a Form 483 with 5 observations to Raritan Pharmaceuticals, Inc in East Brunswick, New Jersey (FEI 3004083931) after an inspection that ran Dec 5, 2017 – Jan 8, 2018. The investigator was Guerlain Ulysse. Most observations concern laboratory controls and quality system.
At a glance
Laboratory controls and quality system account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 02
There is no written assessment of stability of homeopathic drug products based at least on marketing…
- 03
Written records of investigation of a drug complaint do not include the findings of the…
- 04
Written records are not always made of…
This inspection in context
Guerlain Ulysse
32 documents · 2016–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
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 211.160(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Raritan Pharmaceuticals, Inc?
FDA listed 5 observations on this Form 483, mostly about laboratory controls, quality system and materials. The opening words of each observation are shown on this page.
Who inspected Raritan Pharmaceuticals, Inc?
Guerlain Ulysse is named on this Form 483, for the inspection of Dec 5, 2017 – Jan 8, 2018. Each investigator has a profile showing what they cite most.
When was Raritan Pharmaceuticals, Inc inspected by FDA?
The inspection ran Dec 5, 2017 – Jan 8, 2018, and the Form 483 is dated January 8, 2018.
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.