Company
United StatesHikma Pharmaceuticals USA INC., Columbus, OH – FDA Inspections
Inspection records and compliance data for Hikma Pharmaceuticals USA INC. in Columbus, Ohio. 28 FDA inspections on record (1 OAI), 2 Form 483s, last inspected September 18, 2026.
Company Profile
This profile covers Hikma Pharmaceuticals USA INC. based in Columbus, Ohio, United States.
FDA Inspection History
- FDA inspections
- 28
- OAI
- 1
- VAI
- 3
- NAI
- 22
- Unclassified
- 2
- Form 483s
- 2
- Warning letters
- 0
First inspected May 6, 2009. Last inspected September 18, 2026.
Most cited issue areas
- Control procedures to monitor and validate performance1 inspection
- Design validation acceptance criteria1 inspection
- Design Validation - Risk analysis not performed/inadequate1 inspection
FDA inspections (28)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 18, 2026 | Not classified | Human Drugs | 1285748 |
| April 30, 2026 | NAI | · Drug Quality Assurance | 1303412 |
| January 17, 2025 | Not classified | Human Drugs | 1238509 |
| July 23, 2024 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1243797 |
| September 15, 2022 | NAI | Human Drugs · Drug Quality Assurance | 1182363 |
| November 22, 2019 | NAI | Human Drugs · Drug Quality Assurance | 1113855 |
| April 16, 2019 | NAI | Human Drugs · Drug Quality Assurance | 1090395 |
| April 18, 2018 | VAI | Human Drugs · Drug Quality Assurance | 1049821 |
| September 19, 2017 | NAI | Human Drugs · Drug Quality Assurance | 1028066 |
| August 29, 2017 | NAI | Human Drugs · Drug Quality Assurance | 1025782 |
| May 18, 2017 | NAI | Human Drugs · Drug Quality Assurance | 1012430 |
| April 14, 2017 | NAI | Human Drugs · Drug Quality Assurance | 1009022 |
| October 21, 2016 | OAI | Human Drugs, Medical Devices & Rad Health · Generic Drug Evaluation | 994023 |
| July 28, 2016 | NAI | Human Drugs · Drug Quality Assurance | 979525 |
| August 14, 2015 | NAI | Human Drugs · Drug Quality Assurance | 938163 |
| June 26, 2015 | NAI | Human Drugs · Drug Quality Assurance | 933431 |
| June 26, 2014 | VAI | Human Drugs · Bioresearch Monitoring | 885328 |
| May 21, 2014 | NAI | Human Drugs · Drug Quality Assurance | 879765 |
| December 20, 2013 | NAI | Human Drugs · Drug Quality Assurance | 859695 |
| April 24, 2013 | NAI | Human Drugs · Bioresearch Monitoring | 828588 |
| November 30, 2012 | NAI | Human Drugs · Drug Quality Assurance | 812459 |
| October 11, 2012 | NAI | Human Drugs · Drug Quality Assurance | 803101 |
| June 29, 2012 | NAI | Human Drugs · Drug Quality Assurance | 787208 |
| March 7, 2012 | NAI | Human Drugs · Drug Quality Assurance | 770811 |
| October 21, 2011 | NAI | Human Drugs · Drug Quality Assurance | 750318 |
| January 20, 2011 | VAI | Human Drugs · Drug Quality Assurance | 709567 |
| February 24, 2010 | NAI | Human Drugs · Drug Quality Assurance | 648061 |
| May 6, 2009 | NAI | Human Drugs · Drug Quality Assurance | 566711 |
FDA documents
EIRs (1)
People (1)
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Company Information
Name
Hikma Pharmaceuticals USA INC.
FEI Number
1510690
Address
1809 Wilson Rd, Columbus, Ohio 43228, United States
Country
United States
ID: 6289cb89-1444-49a0-91b0-75a04e5152eb