Imprimis NJOF, LLC
Form 483 issued August 18, 2026 · Ledgewoo d, New Jersey
- Inspection
- Aug 4 – Aug 18, 2026
- Investigators
- Annet R. Rajan· Lucila B. Nwatu· Simone E. Pitts
- Observations
- 6
- Pages
- 22
- FEI number
- 3013024146
In short: On August 18, 2026, FDA issued a Form 483 with 6 observations to Imprimis NJOF, LLC in Ledgewoo d, New Jersey (FEI 3013024146) after an inspection that ran Aug 4 – Aug 18, 2026. The investigators were Annet R. Rajan, Lucila B. Nwatu and Simone E. Pitts. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and laboratory controls account for 4 of 6 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
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 03
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 04
Your firm failed to establish written procedures for production and process controls designed to assure that…
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 6 observations on this Form 483, mostly about quality system, laboratory controls 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, Lucila B. Nwatu and Simone E. Pitts are named on this Form 483, for the inspection of Aug 4 – Aug 18, 2026. Each investigator has a profile showing what they cite most.
When was Imprimis NJOF, LLC inspected by FDA?
The inspection ran Aug 4 – Aug 18, 2026, and the Form 483 is dated August 18, 2026.
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.