Imprimis NJOF, LLC
Form 483 issued July 10, 2017 · Ledgewood, New Jersey
- Inspection
- Apr 24, 2017
- Investigators
- Carolyn E. Becker· Helen Verdel· Jose M. Cayuela
- Observations
- 12
- Pages
- 7
- FEI number
- 3013024146
In short: On July 10, 2017, FDA issued a Form 483 with 12 observations to Imprimis NJOF, LLC in Ledgewood, New Jersey (FEI 3013024146) after an inspection that ran Apr 24, 2017. The investigators were Carolyn E. Becker, Helen Verdel, Jose M. Cayuela and Louis An. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
Observations span 4 systems, led by production.
Most cited: 21 CFR 211.84 (3×) · 211.22 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Aseptic processing areas are deficient regarding the system…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 03
Written procedures for cleaning and maintenance fail to include description in sufficient detail of methods…
- 04
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
This inspection in context
Carolyn E. Becker
1 document · 2017
Cites 211.84 (testing and approval or rejection of components, drug product containers, and closures) 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 211.84
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Imprimis NJOF, LLC?
FDA listed 12 observations on this Form 483, mostly about production, quality system and materials. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected Imprimis NJOF, LLC?
Carolyn E. Becker, Helen Verdel, Jose M. Cayuela and Louis An are named on this Form 483, for the inspection of Apr 24, 2017. Each investigator has a profile showing what they cite most.
When was Imprimis NJOF, LLC inspected by FDA?
The inspection ran Apr 24, 2017, and the Form 483 is dated July 10, 2017.
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.