Hikma Pharmaceuticals USA Inc.
Form 483 issued June 12, 2024 · Cherry Hill, New Jersey
- Inspection
- May 29 – Jun 12, 2024
- Investigators
- Azeezat M. Lawal· Christian F. Gomez Lugo· Christina K. Theodorou
- Observations
- 3
- Pages
- 4
- FEI number
- 2220525
In short: On June 12, 2024, FDA issued a Form 483 with 3 observations to Hikma Pharmaceuticals USA Inc. in Cherry Hill, New Jersey (FEI 2220525) after an inspection that ran May 29 – Jun 12, 2024. The investigators were Azeezat M. Lawal, Christian F. Gomez Lugo, Christina K. Theodorou and Yoriann M. Cabrera Bartolomei. Most observations concern production and laboratory controls.
At a glance
Production and laboratory controls account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent objectionable microorganisms in diug products not required to be sterile are…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 03
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Azeezat M. Lawal
8 documents · 2023–2025
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Maryland.
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 211.113(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Hikma Pharmaceuticals USA Inc.?
FDA listed 3 observations on this Form 483, mostly about production, laboratory controls and quality system. The opening words of each observation are shown on this page.
Who inspected Hikma Pharmaceuticals USA Inc.?
Azeezat M. Lawal, Christian F. Gomez Lugo, Christina K. Theodorou and Yoriann M. Cabrera Bartolomei are named on this Form 483, for the inspection of May 29 – Jun 12, 2024. Each investigator has a profile showing what they cite most.
When was Hikma Pharmaceuticals USA Inc. inspected by FDA?
The inspection ran May 29 – Jun 12, 2024, and the Form 483 is dated June 12, 2024.
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.