Hikma Pharmaceuticals USA Inc.
Form 483 issued November 3, 2023 · Cherry Hill, New Jersey
- Inspection
- Oct 23 – Nov 3, 2023
- Investigators
- Lori M. Newman· Sean R. Marcsisin
- Observations
- 5
- Pages
- 6
- FEI number
- 2220525
In short: On November 3, 2023, FDA issued a Form 483 with 5 observations to Hikma Pharmaceuticals USA Inc. in Cherry Hill, New Jersey (FEI 2220525) after an inspection that ran Oct 23 – Nov 3, 2023. The investigators were Lori M. Newman and Sean R. Marcsisin. Most observations concern materials and quality system.
At a glance
Observations span 4 systems, led by materials.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Drug product component testing is deficient in that at least one specific test to verify the…
- 02
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 03
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would…
- 04
An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning…
This inspection in context
Lori M. Newman
18 documents · 2021–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Massachusetts.
The firmHikma Pharmaceuticals USA Inc. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.84
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Hikma Pharmaceuticals USA Inc.?
FDA listed 5 observations on this Form 483, mostly about materials, quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Hikma Pharmaceuticals USA Inc.?
Lori M. Newman and Sean R. Marcsisin are named on this Form 483, for the inspection of Oct 23 – Nov 3, 2023. Each investigator has a profile showing what they cite most.
When was Hikma Pharmaceuticals USA Inc. inspected by FDA?
The inspection ran Oct 23 – Nov 3, 2023, and the Form 483 is dated November 3, 2023.
How do I get the full Form 483 for Hikma Pharmaceuticals USA Inc.?
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.