Hikma Injectables USA Inc.
Form 483 issued June 25, 2024 · Dayton, New Jersey
- Inspection
- Jun 10 – Jun 25, 2024
- Investigators
- Edmund F. Mrak· Luxuly Abraham· Ogechi C. Nna
- Observations
- 4
- Pages
- 6
- FEI number
- 3022897129
In short: On June 25, 2024, FDA issued a Form 483 with 4 observations to Hikma Injectables USA Inc. in Dayton, New Jersey (FEI 3022897129) after an inspection that ran Jun 10 – Jun 25, 2024. The investigators were Edmund F. Mrak, Luxuly Abraham and Ogechi C. Nna. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and laboratory controls account for 4 of 4 observations.
Most cited: 21 CFR 211.42 (2×) · 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency paiiiculate air…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Samples taken of drug products for determination of conformance to written…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
This inspection in context
Edmund F. Mrak
30 documents · 2010–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New York.
The firmHikma Injectables 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 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Hikma Injectables USA Inc.?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Hikma Injectables USA Inc.?
Edmund F. Mrak, Luxuly Abraham and Ogechi C. Nna are named on this Form 483, for the inspection of Jun 10 – Jun 25, 2024. Each investigator has a profile showing what they cite most.
When was Hikma Injectables USA Inc. inspected by FDA?
The inspection ran Jun 10 – Jun 25, 2024, and the Form 483 is dated June 25, 2024.
How do I get the full Form 483 for Hikma Injectables 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.