RIJ Pharmaceutical LLC
Form 483 issued April 13, 2018 · Middletown, New York
- Inspection
- Apr 3 – Apr 13, 2018
- Investigators
- Lata Mathew· Unnee Ranjan
- Observations
- 1
- Pages
- 8
- FEI number
- 1000120212
In short: On April 13, 2018, FDA issued a Form 483 with 1 observation to RIJ Pharmaceutical LLC in Middletown, New York (FEI 1000120212) after an inspection that ran Apr 3 – Apr 13, 2018. The investigators were Lata Mathew and Unnee Ranjan. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×)
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review the failure of a batch or any of its…
This inspection in context
Lata Mathew
24 documents · 2017–2024
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
The firmRIJ Pharmaceutical LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at RIJ Pharmaceutical LLC?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected RIJ Pharmaceutical LLC?
Lata Mathew and Unnee Ranjan are named on this Form 483, for the inspection of Apr 3 – Apr 13, 2018. Each investigator has a profile showing what they cite most.
When was RIJ Pharmaceutical LLC inspected by FDA?
The inspection ran Apr 3 – Apr 13, 2018, and the Form 483 is dated April 13, 2018.
How do I get the full Form 483 for RIJ Pharmaceutical 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.