June Jacobs Labs, LLC
Form 483 issued November 4, 2024 · Moonachie, New Jersey
- Inspection
- Oct 23 – Nov 4, 2024
- Investigator
- Frederick Razzaghi
- Observations
- 3
- Pages
- 3
- FEI number
- 3002832995
In short: On November 4, 2024, FDA issued a Form 483 with 3 observations to June Jacobs Labs, LLC in Moonachie, New Jersey (FEI 3002832995) after an inspection that ran Oct 23 – Nov 4, 2024. The investigator was Frederick Razzaghi. Most observations concern quality system and packaging & labeling.
At a glance
Quality system and packaging & labeling account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
Written records are not made of investigations into the failure of a batch or any of…
- 02
Labeling and packaging materials are not representatively sampled and examined upon receipt and before use in…
- 03
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
This inspection in context
Frederick Razzaghi
15 documents · 2014–2024
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New Jersey.
The firmJune Jacobs Labs, LLC history
The site's inspection history, in date order.
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 June Jacobs Labs, LLC?
FDA listed 3 observations on this Form 483, mostly about quality system, packaging & labeling and laboratory controls. The opening words of each observation are shown on this page.
Who inspected June Jacobs Labs, LLC?
Frederick Razzaghi is named on this Form 483, for the inspection of Oct 23 – Nov 4, 2024. Each investigator has a profile showing what they cite most.
When was June Jacobs Labs, LLC inspected by FDA?
The inspection ran Oct 23 – Nov 4, 2024, and the Form 483 is dated November 4, 2024.
How do I get the full Form 483 for June Jacobs Labs, 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.