Hikma Pharmaceuticals USA Inc.
Form 483 issued September 10, 2019 · Cherry Hill, New Jersey
- Inspection
- Sep 10, 2019
- Investigator
- Win B. Hii
- Observations
- 4
- Pages
- 2
- FEI number
- 2220525
In short: On September 10, 2019, FDA issued a Form 483 with 4 observations to Hikma Pharmaceuticals USA Inc. in Cherry Hill, New Jersey (FEI 2220525) after an inspection that ran Sep 10, 2019. The investigator was Win B. Hii. Most observations concern laboratory controls and quality system.
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
Stability data does not support the…
- 02
There is a failure to thoroughly review the failure of a batch or any of its…
- 03
A device history record has…
- 04
Procedures for design review…
This inspection in context
Win B. Hii
1 document · 2019
Cites 211.166 (stability testing) more than any other section. Most of their documents are for sites in New Jersey.
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 211.166
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Hikma Pharmaceuticals USA Inc.?
FDA listed 4 observations on this Form 483, mostly about laboratory controls, quality system and records & documents. The opening words of each observation are shown on this page.
Who inspected Hikma Pharmaceuticals USA Inc.?
Win B. Hii is named on this Form 483, for the inspection of Sep 10, 2019. Each investigator has a profile showing what they cite most.
When was Hikma Pharmaceuticals USA Inc. inspected by FDA?
The inspection ran Sep 10, 2019, and the Form 483 is dated September 10, 2019.
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.