Imprimis NJOF, LLC
Form 483 issued January 29, 2021 · Ledgew.ood, New Jersey
- Inspection
- Sep 28, 2020 – Jan 29, 2021
- Investigators
- Emmanuel J. Ramos· Helen Verdel· Janet A. Rajan
- Observations
- 8
- Pages
- 21
- FEI number
- 3013024146
In short: On January 29, 2021, FDA issued a Form 483 with 8 observations to Imprimis NJOF, LLC in Ledgew.ood, New Jersey (FEI 3013024146) after an inspection that ran Sep 28, 2020 – Jan 29, 2021. The investigators were Emmanuel J. Ramos, Helen Verdel and Janet A. Rajan. Most observations concern quality system and production.
At a glance
Quality system and production account for 6 of 8 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
(REPEAT OBSERVATION) The.re is a failure to thoroughly review any unexplained d_~crepancy, the failure of a…
- 02
(REPEAT OB$ERVATION) There are no writt~~ procedures for production and process controls designed to assure that…
- 03
. (REPEAT OBSERVATION) Procedures designed to prevent microbiological contamination of drug products purporting to 'be…
- 05
(REPEAT OBSERVATION) The quality col!ltrol unit lacks the.J_"esponsibility and authority to reject all in process…
This inspection in context
Emmanuel J. Ramos
9 documents · 2017–2021
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 8 observations on this Form 483, mostly about quality system, production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Imprimis NJOF, LLC?
Emmanuel J. Ramos, Helen Verdel and Janet A. Rajan are named on this Form 483, for the inspection of Sep 28, 2020 – Jan 29, 2021. Each investigator has a profile showing what they cite most.
When was Imprimis NJOF, LLC inspected by FDA?
The inspection ran Sep 28, 2020 – Jan 29, 2021, and the Form 483 is dated January 29, 2021.
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.