Imprimis NJOF, LLC
Form 483 issued April 3, 2024 · Ledgewood, New Jersey
- Inspection
- Apr 3, 2024
- Investigators
- Annet R. Rajan· Janet A. Rajan· Rose Jean-Mary
- Observations
- 5
- Pages
- 11
- FEI number
- 3013024146
In short: On April 3, 2024, FDA issued a Form 483 with 5 observations to Imprimis NJOF, LLC in Ledgewood, New Jersey (FEI 3013024146) after an inspection that ran Apr 3, 2024. The investigators were Annet R. Rajan, Janet A. Rajan, Rose Jean-Mary and Tomika Crafter. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Laboratory controls and quality system account for 3 of 5 observations.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Drug products failing to meet established…
- 02
There is a failure to thoroughly review any unexplained discrepancy or the failure of a batch…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures…
This inspection in context
Annet R. Rajan
16 documents · 2020–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in New Jersey.
The firmImprimis NJOF, LLC history
All 5 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 Imprimis NJOF, LLC?
FDA listed 5 observations on this Form 483, mostly about laboratory controls, quality system and production. 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 Imprimis NJOF, LLC?
Annet R. Rajan, Janet A. Rajan, Rose Jean-Mary and Tomika Crafter are named on this Form 483, for the inspection of Apr 3, 2024. Each investigator has a profile showing what they cite most.
When was Imprimis NJOF, LLC inspected by FDA?
The inspection ran Apr 3, 2024, and the Form 483 is dated April 3, 2024.
How do I get the full Form 483 for Imprimis NJOF, 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.