Hikma Injectables USA Inc.
FDA inspection history in Dayton, New Jersey, 2022 to 2025
- 3
- Form 483s
Every document, by year
- Form 483
2022: one Form 483; 2024: one Form 483; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2022–25Three Form 483s, at Dayton, New Jersey.
- 2024The longest 483 on file: 4 observations over 6 pages at Dayton, New Jersey.
Cited most
Across all Hikma Injectables USA observations on file
- 21 CFR 211.42Design and construction features5
- 21 CFR 211.160General requirements2
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.166(b)Stability testing1
The complete Hikma Injectables USA file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Dayton, New Jersey
Three Form 483s · 2022 to 2025 · 11 observations
Latest: Form 483, Aug 8, 2025 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-08-08 | 483 Form 483 | Dayton, New Jersey | 4 | $99 |
| 2024-06-25 | 483 Form 483 | Dayton, New Jersey | 4 | $99 |
| 2022-06-08 | 483 Form 483 | Dayton, New Jersey | 3 | $99 |
Investigators on these documents
Edmund F. Mrak (2)Erik W. Koester (1)Jay B. Shah (1)Luxuly Abraham (1)Ogechi C. Nna (1)Rose Jean-Mary (1)Samir C. Gala (1)
FEI number 3022897129 · most recent document Aug 8, 2025
About Hikma Injectables USA Inc.
How many FDA Form 483s has Hikma Injectables USA Inc. received?
FDA Intel has 3 Form 483s on file for Hikma Injectables USA Inc.; the most recent is dated Aug 8, 2025.
When was Hikma Injectables USA Inc. last inspected by FDA?
The most recent FDA inspection document on file for Hikma Injectables USA Inc. is a Form 483 dated Aug 8, 2025, for the site in Dayton, New Jersey.
What did FDA cite at Hikma Injectables USA Inc.?
The regulations cited most in the observations on file for Hikma Injectables USA Inc. are 21 CFR 211.42 (Design and construction features), 5 times; 21 CFR 211.160 (General requirements), 2 times; 21 CFR 211.100 (Written procedures; deviations), 1 time.