Hikma Pharmaceuticals USA Inc.
FDA inspection history in Cherry Hill, New Jersey, 2019 to 2024
- 3
- Form 483s
Every document, by year
- Form 483
2019: one Form 483; 2023: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019One Form 483, at Cherry Hill, New Jersey.
- 2023–24Two Form 483s, at Cherry Hill, New Jersey.
- 2023The longest 483 on file: 5 observations over 6 pages at Cherry Hill, New Jersey.
Cited most
Across all Hikma Pharmaceuticals USA observations on file
- 21 CFR 211.192Production record review2
- 21 CFR 211.113(a)Control of microbiological contamination1
- 21 CFR 211.160(b)General requirements1
- 21 CFR 211.166Stability testing1
- 21 CFR 211.194Laboratory records1
The complete Hikma Pharmaceuticals 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
Cherry Hill, New Jersey
Three Form 483s · 2019 to 2024 · 12 observations
Latest: Form 483, Jun 12, 2024 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-06-12 | 483 Form 483 | Cherry Hill, New Jersey | 3 | $99 |
| 2023-11-03 | 483 Form 483 | Cherry Hill, New Jersey | 5 | $99 |
| 2019-09-10 | 483 Form 483 | Cherry Hill, New Jersey | 4 | $99 |
Investigators on these documents
Azeezat M. Lawal (1)Christian F. Gomez Lugo (1)Christina K. Theodorou (1)Lori M. Newman (1)Sean R. Marcsisin (1)Win B. Hii (1)Yoriann M. Cabrera Bartolomei (1)
FEI number 2220525 · most recent document Jun 12, 2024
About Hikma Pharmaceuticals USA Inc.
How many FDA Form 483s has Hikma Pharmaceuticals USA Inc. received?
FDA Intel has 3 Form 483s on file for Hikma Pharmaceuticals USA Inc.; the most recent is dated Jun 12, 2024.
When was Hikma Pharmaceuticals USA Inc. last inspected by FDA?
The most recent FDA inspection document on file for Hikma Pharmaceuticals USA Inc. is a Form 483 dated Jun 12, 2024, for the site in Cherry Hill, New Jersey.
What did FDA cite at Hikma Pharmaceuticals USA Inc.?
The regulations cited most in the observations on file for Hikma Pharmaceuticals USA Inc. are 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.113(a) (Control of microbiological contamination), 1 time; 21 CFR 211.160(b) (General requirements), 1 time.