Cosmax Usa, Corporation
Form 483 issued December 22, 2014 · Carteret, New Jersey
- Inspection
- Dec 15 – Dec 22, 2014
- Investigator
- Frederick Razzaghi
- Observations
- 4
- Pages
- 2
- FEI number
- 3002679704
In short: On December 22, 2014, FDA issued a Form 483 with 4 observations to Cosmax Usa, Corporation in Carteret, New Jersey (FEI 3002679704) after an inspection that ran Dec 15 – Dec 22, 2014. The investigator was Frederick Razzaghi. Most observations concern laboratory controls and facilities & equipment.
At a glance
Observations span 4 systems, led by laboratory controls.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The written stability program for drug products does not…
- 02
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 03
Written records are not made of…
- 04
Master production and control records lack a statement of theoretical yield including the maximum and minimum…
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 firmCosmax Usa, Corporation history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.166
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Cosmax Usa, Corporation?
FDA listed 4 observations on this Form 483, mostly about laboratory controls, facilities & equipment and quality system. The opening words of each observation are shown on this page.
Who inspected Cosmax Usa, Corporation?
Frederick Razzaghi is named on this Form 483, for the inspection of Dec 15 – Dec 22, 2014. Each investigator has a profile showing what they cite most.
When was Cosmax Usa, Corporation inspected by FDA?
The inspection ran Dec 15 – Dec 22, 2014, and the Form 483 is dated December 22, 2014.
How do I get the full Form 483 for Cosmax Usa, Corporation?
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.