Company
JordanHikma Pharmaceuticals LLC, Amman, Jordan – FDA Inspections
Inspection records and compliance data for Hikma Pharmaceuticals LLC in Amman. 5 FDA inspections on record, 1 Form 483, last inspected September 05, 2019.
Company Profile
This profile covers Hikma Pharmaceuticals LLC based in Amman, Jordan.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 3
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected February 4, 2010. Last inspected September 5, 2019.
Most cited issue areas
- Test methods2 inspections
- Control procedures to monitor and validate performance1 inspection
- Handling and Storage to Prevent Contamination1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 5, 2019 | VAI | Human Drugs · Drug Quality Assurance | 1101407 |
| July 27, 2016 | VAI | Human Drugs · Drug Quality Assurance | 981353 |
| June 25, 2015 | VAI | Human Drugs · Drug Quality Assurance | 935111 |
| April 12, 2012 | NAI | Human Drugs · Drug Quality Assurance | 782232 |
| February 4, 2010 | NAI | Human Drugs · Drug Quality Assurance | 645014 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Hikma Pharmaceuticals LLC
FEI Number
3002806351
Address
Hikma Pharmaceuticals Saleem Bin Al Hareth Street, Building No. (21) Bayader Wadi El Seer Industrial Area, Amman, Jordan
Country
Jordan
ID: 85cbc2fc-4814-4b0b-aaff-a6d0e60238d3