Hikma Injectables USA Inc.
Form 483 issued August 8, 2025 · Dayton, New Jersey
- Inspection
- Jul 28 – Aug 8, 2025
- Investigators
- Erik W. Koester· Rose Jean-Mary
- Observations
- 4
- Pages
- 4
- FEI number
- 3022897129
In short: On August 8, 2025, FDA issued a Form 483 with 4 observations to Hikma Injectables USA Inc. in Dayton, New Jersey (FEI 3022897129) after an inspection that ran Jul 28 – Aug 8, 2025. The investigators were Erik W. Koester and Rose Jean-Mary. Most observations concern production and facilities & equipment.
At a glance
Production and facilities & equipment account for 4 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm failed to establish written procedures for production and process controls designed to assure that…
- 02
Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent contamination that…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be…
This inspection in context
Erik W. Koester
40 documents · 2006–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Massachusetts.
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 211.100
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 production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Hikma Injectables USA Inc.?
Erik W. Koester and Rose Jean-Mary are named on this Form 483, for the inspection of Jul 28 – Aug 8, 2025. Each investigator has a profile showing what they cite most.
When was Hikma Injectables USA Inc. inspected by FDA?
The inspection ran Jul 28 – Aug 8, 2025, and the Form 483 is dated August 8, 2025.
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.