Hikma Injectables USA Inc.
Form 483 issued June 8, 2022 · Dayton, New Jersey
- Inspection
- May 23 – Jun 8, 2022
- Investigators
- Edmund F. Mrak· Jay B. Shah· Samir C. Gala
- Observations
- 3
- Pages
- 5
- FEI number
- 3022897129
In short: On June 8, 2022, FDA issued a Form 483 with 3 observations to Hikma Injectables USA Inc. in Dayton, New Jersey (FEI 3022897129) after an inspection that ran May 23 – Jun 8, 2022. The investigators were Edmund F. Mrak, Jay B. Shah and Samir C. Gala. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
2 of 3 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Aseptic processing areas are deficient regarding the system…
- 02
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air…
- 03
An adequate number of batches of each drug product are not tested to determine…
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(c)(10)(iv)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Hikma Injectables USA Inc.?
FDA listed 3 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, Jay B. Shah and Samir C. Gala are named on this Form 483, for the inspection of May 23 – Jun 8, 2022. Each investigator has a profile showing what they cite most.
When was Hikma Injectables USA Inc. inspected by FDA?
The inspection ran May 23 – Jun 8, 2022, and the Form 483 is dated June 8, 2022.
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.